It appears to me that Vyvanse is now available. I haven't asked at a pharmacy, but the website no longer says, "coming in July," and my insurance company has it listed on the formulary.

If anyone tries this drug out, let us know!

Isn't is just Adderall with some new extra feature (i.e. it can't be 'abused' by junkies because of some sort of enzyme that makes it work only if you swallow it)?

My understanding (and correct me if I'm wrong please) was that Shire is just trying to 'extend' it's patent hold on Aderall by tweaking it a little and re-releasing it as Vyvanse???

Isn't is just Adderall with some new extra feature (i.e. it can't be 'abused' by junkies because of some sort of enzyme that makes it work only if you swallow it)?


Vyvanse does appear to have other advantages over Adderall XR and also Dexedrine Spansule


My understanding (and correct me if I'm wrong please) was that Shire is just trying to 'extend' it's patent hold on Aderall by tweaking it a little and re-releasing it as Vyvanse???
I don't know if that's *just* what they are trying to do, but it undoubtedly affects their decisions.
Acknowledged, they are a capitalist corporation and as such want to expand profits as long as possible. (welcome to america ;))
Although that seems to upset some people, it doesn't upset me; that being said, what does concern me (as a person who wants the best medicine avalible for adhd) is a paranoid suspicion they might be suspending innovation until patents expiration dates approach (but this probably isn't the case in a competitive environment–then again ); e.g., Shire paid Noven 5.9M$ to continue developing the amphetamine medicinal patch (in development since 2003 and only recently completed phase 1 trials FDA). With payment, Shire requested changes to the formulation; I just hope they aren't stalling production until 'trump card' is needed, i.e., until 2024 when Vyvanse's patch expires, or probably sooner when a competitor launches a vyvanse-threatening pharmaceutical.

They haven't "tweaked" Adderall, they've "tweaked" dexamphetamine (Dexedrine). Vyvanse (lis-dexamphetamine) is dexamphetamine bonded to an amino acid. They bond must be broken by an enzyme in the stomach in order for the active drug to be present in the body. Since the bonds can't all be broken at once, it seems that only a certain number of reactions can occur at a given time, which is the reason for it being a long acting drug. It takes a while for the enzymes to activate the entire compound.

Shire is trying to promote Vyvanse over Adderall XR, it appears. When you pull up the Adderall XR website you'll see a huge promotion for Vyvanse, with a tiny link to Adderall XR info. (I bet this will change when their 2 other ADHD drugs are ready to be release. One is "super Adderall XR" and the other is guanfacine XR).

In my opinion, there are a couple of blatent errors in this marketing scheme:

1. Vyvanse isn't FDA approved for adult ADHD, while Adderall XR is. This means that some people will not be able to receive prescription drug coverage if their insurance doesn't allow off-label prescriptions.

2. It's not the same drug! To assume that a patient can seamlessly transition from one medication to the other. Not all people will be able to respond or tolerate both equally.

They haven't "tweaked" Adderall, they've "tweaked" dexamphetamine (Dexedrine). Vyvanse (lis-dexamphetamine) is dexamphetamine bonded to an amino acid. They bond must be broken by an enzyme in the stomach in order for the active drug to be present in the body. Since the bonds can't all be broken at once, it seems that only a certain number of reactions can occur at a given time, which is the reason for it being a long acting drug. It takes a while for the enzymes to activate the entire compound.

Shire is trying to promote Vyvanse over Adderall XR, it appears. When you pull up the Adderall XR website you'll see a huge promotion for Vyvanse, with a tiny link to Adderall XR info. (I bet this will change when their 2 other ADHD drugs are ready to be release. One is "super Adderall XR" and the other is guanfacine XR).

In my opinion, there are a couple of blatent errors in this marketing scheme:

1. Vyvanse isn't FDA approved for adult ADHD, while Adderall XR is. This means that some people will not be able to receive prescription drug coverage if their insurance doesn't allow off-label prescriptions.

2. It's not the same drug! To assume that a patient can seamlessly transition from one medication to the other. Not all people will be able to respond or tolerate both equally.Oh, wow. So, you're saying that Vyvanse is essentially Dexedrine that has been modified to make it less addictive?

That's REALLY good news. I was under the impression that it was just Adderall that had been changed up a bit.

But if it's pure Dextroamphetamine, that is VERY good since D-amphetamine is supposedly the 'purest' amphetamine there is avaiable (that is, it doesn't have the l-amphetamine and the other racemic amphetamines you get with Adderall).;)

Bingo on that first statement. Vyvanse is a 'prodrug' meaning it is completely useless and harmless until it passes through the GI tract. Smoking, snorting, injecting will get you NOTHING from it.

Once the amino-acid is cleaved off you have d-amphetamine (dexedrine). One promising feature about Vyvanse is that fact is takes much longer to reach peak and isn't effected by pH like Adderall or Dexedrine is. Adderall is supposed to have a longer time to peak but is highly variable from person to person, day to day (I can vouch for this).

Shire still has patent protection on Adderall XR but has sold 'exclusive' generic rights to Barr to allow them to make a generic form starting in 2008 (I think). They are going to focus heavily on Vyvanse and later this year with the longer acting form of Adderall XR (triple-bead vs the current double-bead).

J

Bingo on that first statement. Vyvanse is a 'prodrug' meaning it is completely useless and harmless until it passes through the GI tract. Smoking, snorting, injecting will get you NOTHING from it.

Once the amino-acid is cleaved off you have d-amphetamine (dexedrine). One promising feature about Vyvanse is that fact is takes much longer to reach peak and isn't effected by pH like Adderall or Dexedrine is. Adderall is supposed to have a longer time to peak but is highly variable from person to person, day to day (I can vouch for this).

Shire still has patent protection on Adderall XR but has sold 'exclusive' generic rights to Barr to allow them to make a generic form starting in 2008 (I think). They are going to focus heavily on Vyvanse and later this year with the longer acting form of Adderall XR (triple-bead vs the current double-bead).

JSo, is Vyvanse essentially 'Dexedrine XR' :p that can't be 'abused'.

Hmmm. I may switch if it really does last as long as they say it does. I like stimulants because of the (relative) lack of side effects - but they don't last long enough (I mean, compared to Strattera for instance).

I'd like to try it because Ritalin LA b.i.d. isn't long-lasting enough or "strong" enough. Where as Adderall XR feels a little too stimulating. Lis-dex seems like a good middle ground. I'm just not sure about my insurance coverage, which requires special approval for all stims.

Adderall XR patent is good until 2018 per the on-line patent office information. I think they are just trying to cover all the basis in order to maintain high market share.

Vyvanse is essentially a new drug from the patent standpoint on the old dexedrine. Since they can't really make any money on dexedrine since the patent is long long past, they have changed it up so that they can patent it. From the standpoint of marketing, the whole Vyvanse concept is brilliant. They say that you can get the benefits of a well known drug without the ability to abuse it.

My pharmacy can now get it and it costs them 665.00 per bottle for 100 count.

Here is a blurb about the Generic Adderall XR agreement from Barr's website:

"The Settlement and License Agreements permit Barr to launch a generic version of ADDERALL XR, under terms of a license commencing on April 1, 2009, more than nine years earlier than the last-to-expire Shire patent listed in the U.S. Food and Drug Administration's Orange Book, or earlier under certain circumstances such as the launch of another party's generic version of ADDERALL XR. The license will be exclusive for the first 180-days following Barr's launch. Barr would pay Shire a royalty equal to a portion of profits generated from the sales of generic ADDERALL XR during the time that Barr is the only generic marketing a generic version of ADDERALL XR. As part of the settlement, Barr admits that Shire's patents are valid and enforceable and that Barr's generic product infringes one of the Shire patents."

Basically from here on out Shire couldn't give a crap about Adderall XR anymore. Focus now is on Vyvanse and the upcoming spd465 (super Adderall XR). So why is Shire allowing Barr to sell generic Adderall XR years before the patent expires? Easy....Money $$$$. Another easy source of revenue for a med they could care much less about but still want it in their portfolio. Why sit on a med when you can let someone have access for it and pay decent money to do so. Smart business!

J

Adderall XR patent is good until 2018 per the on-line patent office information.Please correct me if I am wrong... but I am fairly certain that the patent for Adderall XR expires in 2009.

Please correct me if I am wrong... but I am fairly certain that the patent for Adderall XR expires in 2009.Nope. It expires January 6, 2021. What you're probably refering to is Pediatric Exclusivity which expires on January 21, 2009.

Here's the actual United States patent (http://patft.uspto.gov/netacgi/nph-Parser?u=%2Fnetahtml%2Fsrchnum.htm&Sect1=PTO1&Sect2=HITOFF&p=1&r=1&l=50&f=G&d=PALL&s1=6384020.PN.&OS=PN/6384020&RS=PN/6384020) for Adderall.

I'm on Vyvanse. Have been for about 10 days. My opinions about it's efficacy for me are somewhat mixed. Yes, I am more motivated, clear, attentive, focused, all that good stuff. But it also imparts too much of a buzzy/speedy feeling that I don't really like - the same sort of sensation I would get from taking ephedrine bull****, ugghhh. I also think I'm way more impulsive on Vyvanse than what I am even normally. For me, Adderall XR is definitely the superior medication - it does all the positive things the Vyvanse does - moreso even - yet without any of the negatives that Vyvanse seems to have. It made me much calmer, less impulsive, and everything just seemed... smoother and chill when I was on it. And wow, I was a lot nicer than I normally am too, which was by far the most awesome part to me. I'm wondering if the levo-amphetamine in Adderall does something critically important for my particular case of ADHD. I haven't been able to dig up any information on this though.

Anyone else taken Vyvanse yet? I'm really curious what other people's experiences have been with it, particularly in comparison to Adderall. It's interesting because from what I have been able to find, at least as far as Dexedrine vs. Adderall comparisons go, it seems straight dextro-amphetamine makes people feel "smoother" and the Adderall gives them too much of a buzzy sensation. Whereas it's completely the reverse in my case.

I'm on Vyvanse. Have been for about 10 days. My opinions about it's efficacy for me are somewhat mixed. Yes, I am more motivated, clear, attentive, focused, all that good stuff. But it also imparts too much of a buzzy/speedy feeling that I don't really like - the same sort of sensation I would get from taking ephedrine bull****, ugghhh. I also think I'm way more impulsive on Vyvanse than what I am even normally. For me, Adderall XR is definitely the superior medication - it does all the positive things the Vyvanse does - moreso even - yet without any of the negatives that Vyvanse seems to have. It made me much calmer, less impulsive, and everything just seemed... smoother and chill when I was on it. And wow, I was a lot nicer than I normally am too, which was by far the most awesome part to me. I'm wondering if the levo-amphetamine in Adderall does something critically important for my particular case of ADHD. I haven't been able to dig up any information on this though.

Anyone else taken Vyvanse yet? I'm really curious what other people's experiences have been with it, particularly in comparison to Adderall. It's interesting because from what I have been able to find, at least as far as Dexedrine vs. Adderall comparisons go, it seems straight dextro-amphetamine makes people feel "smoother" and the Adderall gives them too much of a buzzy sensation. Whereas it's completely the reverse in my case.What dose are you on? If you're feel like you're taking 'speed' its because the dose is probably too high. Is your heart beating faster?

The way these amphetamines work is that they attach themselves to dopamine transporters and thus block the transporters from being attached to dopamine - since the dopamine isn't getting transported anywhere - it just sits there and builds up and thus your dopamine levels increase.

ADD people have low dopamine levels and thus can't concentrate. Normal dopamine levels let you concentrate. HIGH doapmine levels give you the 'speed' feeling - you get that when you take too much amphetamine, or take cocaine or other powerful stimulants.

What dose are you on? If you're feel like you're taking 'speed' its because the dose is probably too high. Is your heart beating faster?

The way these amphetamines work is that they attach themselves to dopamine transporters and thus block the transporters from being attached to dopamine - since the dopamine isn't getting transported anywhere - it just sits there and builds up and thus your dopamine levels increase.

ADD people have low dopamine levels and thus can't concentrate. Normal dopamine levels let you concentrate. HIGH doapmine levels give you the 'speed' feeling - you get that when you take too much amphetamine, or take cocaine or other powerful stimulants.

It's unknown exactly how amphetamines alleviate adhd symptoms.

What dose are you on? If you're feel like you're taking 'speed' its because the dose is probably too high. Is your heart beating faster?

The way these amphetamines work is that they attach themselves to dopamine transporters and thus block the transporters from being attached to dopamine - since the dopamine isn't getting transported anywhere - it just sits there and builds up and thus your dopamine levels increase.

ADD people have low dopamine levels and thus can't concentrate. Normal dopamine levels let you concentrate. HIGH doapmine levels give you the 'speed' feeling - you get that when you take too much amphetamine, or take cocaine or other powerful stimulants.

Ya, I know how amphetamines work and what the most likely model is for why they are beneficial for treating ADHD symptoms.

I've been taking 30mg, which is the lowest dose. It is supposedly comparable to 10mg Adderall XR. My heart rate isn't elevated, it's still normal, I've checked a few times. And my hands don't shake or anything like that. But for some reason it just makes me feel wired and I don't like that. And it's like I just *have* to be up and moving around and physically doing things, or else I will start to feel like **** because it's like the buzzy sensation just escalates if you don't get up and shake it off by moving. All in all, this isn't a horrible thing - it's certainly a quantum leap up from my usual state(s). But I know based on my Adderall experience, that I could and should be having better results than this.

If I remember correctly, a 30mg of Vyvanse contains 8.88mg of dextro-amphetamine. However, I've read that it's important not to take that number too literally as the pharmacokinetics of Vyvanse and how it's metabolized by the body are rather different from other forms of amphetamine. So the effects of taking it will be supposedly be very different from say, taking a dexedrine spanule containing an equivalent amount of dextro. Which may have something to do with why it's not optimally agreeing with me, I'm not sure.

Nope. It expires January 6, 2021.You're saying the patent for Adderall XR doesn't expire until 2021??? In other words.... No generic Adderall XR will become available until 2021? :confused:

I'm sorry, but this doesn't sound correct. I was thinking 2009 for Adderall XR. Hmmm........

http://www.sparks.org/HealthNews/Healthday/070226HD602223.htm (second paragraph, last sentence)

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/08-14-2006/0004416041&EDATE= (second paragraph... BARR can start producing generic Adderall XR after April 1, 2009.)

Nope. It expires January 6, 2021. What you're probably refering to is Pediatric Exclusivity which expires on January 21, 2009.

Here's the actual United States patent (http://patft.uspto.gov/netacgi/nph-Parser?u=%2Fnetahtml%2Fsrchnum.htm&Sect1=PTO1&Sect2=HITOFF&p=1&r=1&l=50&f=G&d=PALL&s1=6384020.PN.&OS=PN/6384020&RS=PN/6384020) for Adderall.
The adderall XR patent is patent no 6,913,768. The one you linked to is Adderall immediate release.

http://www.sparks.org/HealthNews/Healthday/070226HD602223.htm (second paragraph, last sentence)

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/08-14-2006/0004416041&EDATE= (second paragraph... BARR can start producing generic Adderall XR after April 1, 2009.)
But, that only allows BARR to produce the generic of XR. It was a settlement of a patent that Shire infringed on when creating Adderall XR and is only between Shire and Barr. You or I would be unable to create a generic if we were a pharmaceutical company.

Bottom line, until there is complete availability to make a generic, you probably will not see a huge price decrease since we are still limited to 2 vendors.

But, that only allows BARR to produce the generic of XR.Correct me if I'm wrong on this, but according to the 2nd link that LittlePrincess provided above it goes on to state that:

"Shire's settlement with Impax Laboratories allows Impax to market a generic version of ADDERALL XR 181 days following Barr's launch."
.

Bottom line, until there is complete availability to make a generic, you probably will not see a huge price decrease since we are still limited to 2 vendors.Well, I would predict that the BARR version of "Adderall XR" will be significantly less expensive than Shire's *brand name* Adderall XR.

This is the reasoning behind Shire pushing Vyvanse. Just check out the website for Adderall XR (www.adderallxr.com)... Shire is trying to switch people over to Vyvanse. Why??? Because other pharmaceutical companies (i.e. BARR) are going to start producing generic equivalents of Adderall XR in less than two years! When that happens, many patients will switch right on over to the generics, meaning less money for Shire! Shire needs those people on SHIRE meds.... i.e. the new VYVANSE.

This is the reasoning behind Shire pushing Vyvanse. Just check out the website for Adderall XR (www.adderallxr.com)... Shire is trying to switch people over to Vyvanse. Why??? Because other pharmaceutical companies (i.e. BARR) are going to start producing generic equivalents of Adderall XR in less than two years! When that happens, many patients will switch right on over to the generics, meaning less money for Shire! Shire needs those people on SHIRE meds.... i.e. the new VYVANSE.

Isn't Shire the one that allowed BARR to do that though? And if they're trying to switch everyone over to Vyvanse, why would they be coming out with an Adderall XXR? And they have the Daytrana patch I believe. It could be that they're just trying to beef up their arsenal of ADHD drugs so they can continue dominating even more of the field.

Isn't Shire the one that allowed BARR to do that though? And if they're trying to switch everyone over to Vyvanse, why would they be coming out with an Adderall XXR? And they have the Daytrana patch I believe. It could be that they're just trying to beef up their arsenal of ADHD drugs so they can continue dominating even more of the field.
Who sayys they are coming out with Adderall XXR? There's a good chance they wont

but anythin we could say on the subject would be just speculation

The Adderall XXR (or whatever name Shire comes up with) will be the formal name for spd465.


J

Is there a generic version of adderall IR on the market? I only pay $10 a bottle, but y not get it cheaper? :)

Lisdexamfetamine for ADHD

<TABLE cellSpacing=0 cellPadding=0 align=right bgColor=#ffffff border=0><TBODY><TR vAlign=top><TD width=177>http://www.currentpsychiatry.com/images/inThisArticle_boxHeader.jpg</IMG></TD></TR><TR vAlign=top><TD><TABLE cellSpacing=0 cellPadding=0 width=177 border=0><TBODY><TR><TD vAlign=top align=left width=1 background=images/1by1GreyBar.jpg>http://www.currentpsychiatry.com/images/1by1GreyBar.jpg</IMG></TD><TD bgColor=#f9faf4><TABLE cellSpacing=0 cellPadding=2 width="100%" border=0><TBODY><TR class=section><TD vAlign=top align=left>•</TD><TD vAlign=top align=left>Clinical implications (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#1)</TD></TR><TR class=section><TD vAlign=top align=left>•</TD><TD vAlign=top align=left>How it works (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#2)</TD></TR><TR class=section><TD vAlign=top align=left>•</TD><TD vAlign=top align=left>Pharmacokinetics (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#3)</TD></TR><TR class=section><TD vAlign=top align=left>•</TD><TD vAlign=top align=left>Efficacy (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#4)</TD></TR><TR class=section><TD vAlign=top align=left>•</TD><TD vAlign=top align=left>Tolerability (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#5)</TD></TR><TR class=section><TD vAlign=top align=left>•</TD><TD vAlign=top align=left>Safety (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#6)</TD></TR><TR class=section><TD vAlign=top align=left>•</TD><TD vAlign=top align=left>Abuse potential (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#7)</TD></TR><TR class=section><TD vAlign=top align=left>•</TD><TD vAlign=top align=left>Contraindications (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#8)</TD></TR></TBODY></TABLE></TD><TD width=1 background=images/1by1GreyBar.jpg>http://www.currentpsychiatry.com/images/1by1GreyBar.jpg</IMG></TD></TR></TBODY></TABLE></TD></TR><TR vAlign=top><TD>http://www.currentpsychiatry.com/images/rightNavBoxBottom.jpg</IMG></TD></TR></TBODY></TABLE>



Extended-action psychostimulant offers daylong coverage and has comparatively low abuse potential.



Timothy E. Wilens, MD

Associate professor of psychiatry, Harvard Medical School; director, substance abuse services, Clinical and Research Program in Pediatric Pharmacology, Massachusetts General Hospital, Boston

Lisdexamfetamine—FDA-approved to treat attention-deficit/hyperactivity disorder (ADHD) in children ages 6 to 12 (Table 1 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#0606CP_Pipeline-tab1))—reduces ADHD symptoms during and after school and may be less likely to be abused than other psychostimulants, particularly immediate-release preparations, clinical data suggest.

<TABLE class=1 cellSpacing=0 cellPadding=3 width=500 align=center border=1>
Table 1
Lisdexamfetamine: Fast facts <TBODY><TR class=TableRow><TD class="">Brand name: Vyvanse

</TD>

</TR><TR class=TableRow><TD class="">Indication: ADHD in children ages 6 to 12

</TD>

</TR><TR class=TableRow><TD class="">Approval date: February 23, 2007

</TD>

</TR><TR class=TableRow><TD class="">Manufacturers: New River Pharmaceuticals and Shire

</TD>

</TR><TR class=TableRow><TD class="">Dosing forms: 30-, 50-, and 70-mg capsules

</TD>

</TR><TR class=TableRow><TD class="">Recommended dosage: Start at 30 mg/d. If necessary, titrate by 20 mg every 3 to 7 days to a maximum 70 mg/d.

</TD>

</TR></TBODY></TABLE><A id=""><A name=1>

Clinical implications

Because it is effective for about 12 hours, lisdexamfetamine might improve the child’s ability to complete homework and participate in extracurricular activities, which in turn might enhance academic performance and/or socialization skills.

Lisdexamfetamine could help the child with ADHD who shows no contraindications (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#sect1-001) to the drug —particularly if he or she needs daylong coverage.

<A id="">How it works

Lisdexamfetamine—a dextroamphetamine derivative—is rapidly absorbed and converted to dextroamphetamine, which is believed to exert therapeutic effect by:

<LI class=Body>blocking norepinephrine and dopamine reuptake into presynaptic neurons

increasing the neurotransmitters’ release into the extraneuronal space.

The medication’s amphetamine release is highly predictable, which contributes to its therapeutic benefit in ADHD. Amphetamine is released through GI metabolism of lisdexamfetamine, which produces the active d-amphetamine moiety that reaches the bloodstream. The medication is derived from d-amphetamine, with negligible amounts of lysine cleaved.

Lisdexamfetamine requires in vivo metabolism (in the GI tract) to its active constituent d-amphetamine. As a result, the medication will not produce high d-amphetamine blood levels—and should not cause euphoria or other reinforcing effects—if injected or snorted. Its abuse potential is lower overall compared with immediate-release psychostimulant formulations.

<A id="">Pharmacokinetics

Dextroamphetamine’s plasma elimination half-life is approximately 9½ hours—which accounts for lisdexamfetamine’s extended action. The drug reaches steady-state concentrations in 2 to 3 days.

Food does not affect absorption and delays maximum concentration by 1 hour or less, so taking lisdexamfetamine during breakfast should not slow its therapeutic effect. Because dextroamphetamine reaches maximum concentration in approximately 3½ hours, the medication should take effect by the time the child gets to school. In one randomized, phase-2 trial, children with ADHD who received lisdexamfetamine, 30 to 70 mg/d, showed overall improvement within 2 hours after dosing.<SUP>1 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib1)</SUP>

<A id="">Efficacy

Lisdexamfetamine reduced ADHD symptoms in 2 double-blind studies: a phase-2 crossover study and a phase-3 random-dose trial.

Phase-2 crossover study.<SUP>2 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib2)</SUP> Fifty-two children ages 6 to 12 with combined or hyperactive-impulsive type ADHD received extended-release mixed amphetamine salts (MAS) for 3 weeks. Subjects received 10 mg/d or dosages titrated to 20 or 30 mg/d based on response to medication.

The youths then were divided into 3 groups based on optimal MAS dosage and received 3 treatments for 1 week each:

<LI class=Body>group 1: placebo; MAS, 10 mg/d; lisdexamfetamine, 30 mg/d

<LI class=Body>group 2: placebo; MAS, 20 mg/d; lisdexamfetamine, 50 mg/d

group 3: placebo; MAS, 30 mg/d; lisdexamfetamine, 70 mg/d.

While taking lisdexamfetamine or MAS, subjects showed similar improvement in behavior, based on Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) scores, and inattention, based on SKAMP and Permanent Product Measure of Performance scores.

Both psychostimulants outperformed placebo in both measures, and both improved behavior more decisively than inattention. Based on post-hoc analysis, improvement 12 hours after dosing was more substantial with lisdexamfetamine than with MAS.

<TABLE cellSpacing=1 cellPadding=0 width="40%" align=right bgColor=black border=0><TBODY><TR><TD><TABLE style="BACKGROUND-COLOR: #fafaf5" cellSpacing=0 cellPadding=5 width="100%" border=0><TBODY><TR><TD>Clinical Point

In one study, children with ADHD showed improvement within 2 hours after receiving lisdexamfetamine

</TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE>

Phase-3 random-dose trial.<SUP>3 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib3)</SUP> A total of 290 children ages 6 to 12 with combined or hyperactive-impulsive type ADHD were “washed out” from prior medications over 1 week, then received lisdexamfetamine or placebo for 4 weeks. Treatment-group children were started at 30 mg/d; some received dosages titrated at random to 50 or 70 mg/d in weekly 20-mg increments.

Over 4 weeks, ADHD Rating Scale Version IV (ADHD-RS-IV) scores fell 50% to 59% among the 3 lisdexamfetamine dosage groups, compared with a 15% reduction in the placebo group. Substantial ADHD-RS-IV score improvements after 1 week of lisdexamfetamine were maintained throughout the trial, suggesting the medication sustains ADHD symptom improvement. Controlled trials have not addressed lisdexamfetamine use >4 weeks, however.

Based on parents’ and guardians’ reports, treatment-group patients’ ADHD symptoms were notably less severe at 10 AM, 2 PM, and 6 PM compared with placebo-group children.<SUP>3 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib3)</SUP> This suggests that lisdexamfetamine offers a daylong therapeutic effect.

<A id="">Tolerability

In the phase-3 study,<SUP>3 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib3)</SUP> 162 of 218 (74%) children receiving any dosage of lisdexamfetamine reported an adverse event, compared with 34 of 72 (47%) children in the placebo group. Overall, 39% of lisdexamfetamine-group patients reported decreased appetite. Also common were insomnia, headaches, irritability, upper abdominal pain, vomiting, and weight loss (Table 2 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#0606CP_Pipeline-tab2)).

Although most adverse events were mild to moderate, 9.2% of treatment-group children dropped out because of intolerability, compared with 1.4% of the placebo group. The investigators increased dosages quickly, regardless of efficacy or tolerability,<SUP>3 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib3)</SUP> which might have increased side-effect incidence among the treatment groups.

In the phase-2 crossover trial,<SUP>2 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib2)</SUP> adverse event rates were similar among the lisdexamfetamine, extended-release MAS, and placebo groups (15% to 18%). Among youths receiving lisdexamfetamine, 8% reported insomnia and 6% reported appetite loss, compared with 2% and 4% of the MAS group, respectively.

<TABLE class=1 cellSpacing=0 cellPadding=3 width=500 align=center border=1>
Table 2
Rates of commonly reported adverse effects
during phase-3 lisdexamfetamine (LDX) study <TBODY><TR class=TableHead><TD class="" vAlign=top>Adverse effect

</TD><TD class="" align=middle>LDX 30 mg/d

</TD><TD class="" align=middle>LDX 50 mg/d*

</TD><TD class="" align=middle>LDX 70 mg/d*

</TD><TD class="" align=middle>LDX all dosages

</TD><TD class="" vAlign=top>Placebo

</TD></TR><TR class=TableRow><TD class="" vAlign=top>All adverse effects

</TD><TD class="" align=middle>72%

</TD><TD class="" align=middle>68%

</TD><TD class="" align=middle>84%

</TD><TD class="" align=middle>74%

</TD><TD class="" align=middle>47%

</TD>

</TR><TR class=TableRow><TD class="" vAlign=top>Decreased appetite

</TD><TD class="" align=middle>37%

</TD><TD class="" align=middle>31%

</TD><TD class="" align=middle>49%

</TD><TD class="" align=middle>39%

</TD><TD class="" align=middle>4%

</TD>

</TR><TR class=TableRow><TD class="" vAlign=top>Insomnia

</TD><TD class="" align=middle>16%

</TD><TD class="" align=middle>16%

</TD><TD class="" align=middle>25%

</TD><TD class="" align=middle>19%

</TD><TD class="" align=middle>3%

</TD>

</TR><TR class=TableRow><TD class="" vAlign=top>Upper abdominal pain

</TD><TD class="" align=middle>14%

</TD><TD class="" align=middle>7%

</TD><TD class="" align=middle>15%

</TD><TD class="" align=middle>12%

</TD><TD class="" align=middle>6%

</TD>

</TR><TR class=TableRow><TD class="" vAlign=top>Headache

</TD><TD class="" align=middle>10%

</TD><TD class="" align=middle>10%

</TD><TD class="" align=middle>16%

</TD><TD class="" align=middle>12%

</TD><TD class="" align=middle>10%

</TD>

</TR><TR class=TableRow><TD class="" vAlign=top>Irritability

</TD><TD class="" align=middle>11%

</TD><TD class="" align=middle>8%

</TD><TD class="" align=middle>10%

</TD><TD class="" align=middle>10%

</TD><TD class="" align=middle>0%

</TD>

</TR><TR class=TableRow><TD class="" vAlign=top>Vomiting

</TD><TD class="" align=middle>7%

</TD><TD class="" align=middle>5%

</TD><TD class="" align=middle>14%

</TD><TD class="" align=middle>9%

</TD><TD class="" align=middle>4%

</TD>

</TR><TR class=TableRow><TD class="" vAlign=top>Weight loss

</TD><TD class="" align=middle>6%

</TD><TD class="" align=middle>3%

</TD><TD class="" align=middle>19%

</TD><TD class="" align=middle>9%

</TD><TD class="" align=middle>1%

</TD>

</TR><TR class=TableRow><TD class="" colSpan=6>*Dosages were randomly titrated regardless of efficacy or tolerability.

</TD>

</TR><TR class=TableRow><TD class="" colSpan=6>Source:<A class=Superscript href="http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib3">Reference 3

</TD>

</TR>

</TBODY></TABLE><A id="">

Safety

Findling et al<SUP>4 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib4)</SUP> found a larger change in corrected QT interval with lisdexamfetamine (7 to 14 msec) than with extended-release MAS (5 to 10 msec) 5 and 10½ hours after dosing. The authors reasoned that these findings are atypical, and no children suffered serious adverse events during the trial. Nonetheless, more research on whether lisdexamfetamine increases cardiac risk is needed.

<TABLE cellSpacing=1 cellPadding=0 width="40%" align=right bgColor=black border=0><TBODY><TR><TD><TABLE style="BACKGROUND-COLOR: #fafaf5" cellSpacing=0 cellPadding=5 width="100%" border=0><TBODY><TR><TD>Clinical Point

ADHD Rating Scale score decreases after 1 and 4 weeks suggest that lisdexamfetamine sustains symptom improvement

</TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE>

In a lethal-dose study in rats,<SUP>5 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib5)</SUP> oral lisdexamfetamine doses up to 1,000 mg/kg did not result in death, suggesting the medication might undergo saturation kinetics in the GI tract that may protect against overdose or abuse at higher dosages. By comparison, the median lethal oral dosage of d-amphetamine in rats was 96.8 mg/kg.<SUP>5 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib5)</SUP>

<A id="">Abuse potential

As with other psychostimulants indicated for ADHD, the Drug Enforcement Administration has classified lisdexamfetamine as a schedule II drug, which applies to addictive prescription-only medications with an accepted medical use.

Clinical data suggest, however, that lisdexamfetamine might be less “enjoyable”—and less likely to be abused intravenously, orally, or intranasally—than equipotent d-amphetamine. In an abuse liability study,<SUP>6 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib6)</SUP> 12 adults with histories of stimulant abuse received intravenous immediate-release (IR) d-amphetamine, 10 or 20 mg. Two days later, they received a comparable dose of IV lisdexamfetamine, 25 or 50 mg. The researchers found that:

<LI class=Body>Plasma d-amphetamine peaked within 5 minutes after injection, compared with 2 to 3 hours after lisdexamfetamine dosing.

Subjects who received IR d-amphetamine said they felt euphoria within 15 minutes of injection. By contrast, no one reported euphoria or amphetamine-like subjective effects after receiving lisdexamfetamine.

When asked which medication they would try again, 9 of 12 subjects chose IR d-amphetamine and 1 chose lisdexamfetamine.

In a double-blind, randomized, placebo-controlled study,<SUP>7 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib7)</SUP> oral lisdexamfetamine, 50 or 100 mg, was not more “likeable” than placebo. Subjects reported “liking” effects with 150 mg of lisdexamfetamine, however, suggesting the medication could be misused or abused at higher-than-therapeutic dosages.

<A id=sect1-001>Contraindications

As with other psychostimulants, do not give lisdexamfetamine to youths with preexisting serious structural cardiac abnormalities or other heart problems. Assess patient and family history of heart disease before prescribing this medication.

<TABLE cellSpacing=1 cellPadding=0 width="40%" align=right bgColor=black border=0><TBODY><TR><TD><TABLE style="BACKGROUND-COLOR: #fafaf5" cellSpacing=0 cellPadding=5 width="100%" border=0><TBODY><TR><TD>Clinical Point

Do not prescribe lisdexamfetamine to patients taking an MAOI or who have taken one within 2 weeks of presentation

</TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE>

Do not prescribe lisdexamfetamine to patients taking a monoamine oxidase inhibitor (MAOI). By slowing amphetamine metabolism, these antidepressants intensify amphetamines’ effect on monoamine release, which can cause headaches and lead to hypertensive crisis. Before starting lisdexamfetamine, ask if the patient is taking an MAOI or has taken one within 2 weeks of presentation.

Use caution when prescribing lisdexamfetamine to patients with:

<LI class=Body>a comorbid eating disorder or sleep disturbance. Determine whether to address the comorbidity before treating ADHD symptoms, and make sure lisdexamfetamine is not worsening the comorbid symptoms.

untreated hypertension or other cardiovascular conditions, as stimulant medications can increase blood pressure and heart rate. Watch for significant heart rate and blood pressure changes in patients taking lisdexamfetamine, which probably would not cause sustained blood pressure increase in patients taking antihypertensives.<SUP>8 (http://www.currentpsychiatry.com/article_pages.asp?AID=5064&UID=#bib8)</SUP>



Related resources




Lisdexamfetamine Web site. www.vyvanse.com (http://www.vyvanse.com/).



Drug brand names



<IT>Extended-release mixed amphetamine salts • Adderall XR
</IT><IT>Lisdexamfetamine • Vyvanse
</IT>


Disclosure



Dr. Wilens receives research/grant support from Abbott Laboratories, Eli Lilly and Company, National Institute on Drug Abuse, NeuroSearch, Ortho-McNeil, and Shire; is a speaker for Novartis Pharmaceuticals Corp., Ortho-McNeil, and Shire; and is a consultant to Abbott Laboratories, Eli Lilly and Company, GlaxoSmithKline, National Institute on Drug Abuse, Novartis Pharmaceuticals Corp., Ortho-McNeil, Pfizer, and Shire.

References


Lopez FA, Boellner SW, Childress A, et al. ADHD symptom improvement in children treated with lisdexamfetamine dimesylate (LDX). Poster presented at: Annual Meeting of the American Academy of Child and Adolescent Psychiatry; October 24-29, 2006; San Diego, CA.
Biederman J, Boellner SW, Childress A, et al. Improvements in symptoms of attention-deficit/hyperactivity disorder in school-aged children with lisdexamfetamine (NRP 104) and mixed amphetamine salts, extended-release versus placebo. Poster presented at: Annual Meeting of the American Psychiatric Association; May 20-25, 2006; Toronto, Canada.
Biederman J, Krishnan S, Zhang Y, et al. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP 104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther 2007;29:450–63.
Findling FL, Biederman J, Wilens TE, et al. Short- and long-term cardiovascular effects of mixed amphetamine salts extended release in children. J Pediatr 2005;147:348–54.
Krishnan S. Toxicity profile of lisdexamfetamine dimesylate (LDX NRP104) in three independent rat toxicology studies. Basic Clin Phamacol Toxicol. In press.
Jasinski DR. Abuse liability of intravenous L-lysine-d-amphetamine (NRP 104).Poster presented at: Annual Meeting of the College on Problems of Drug Dependence; June 17-22, 2006; Scottsdale, AZ. Available at: http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=4234033 (http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=4234033). Accessed April 5, 2007.
Jasinski D, Krishnan S. A double-blind, randomized, placebo and active-controlled, six-period crossover study to evaluate the likeability, safety, and abuse liability of NRP 104 in healthy adult volunteers with histories of stimulant abuse (NRP104. A03).Poster presented at: Annual Meeting of the College on Problems of Drug Dependence; June 17-22, 2006; Scottsdale, AZ. Available at: http://www.secinfo.com/d12Pk6.v9Ac.d.htm (http://www.secinfo.com/d12Pk6.v9Ac.d.htm). Accessed May 14, 2007.
Wilens TE, Zusman RM, Hammerness PG, et al. An open-label study of the tolerability of mixed amphetamine salts in adults with attention-deficit/hyperactivity disorder and treated primary essential hypertension. J Clin Psychiatry 2006;67:696–702.
Current Psychiatry ©2007 Dowden Health Media

Adderall XXR??? That sounds kinda cool. hehe :)

Here's what's going on with "Adderall XXR":


19 May 2007 - Basingstoke, U.K., and Philadelphia, U.S. – May 19, 2007 - Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for SPD465 (triple-bead mixed amphetamine salts MAS, an investigational oral stimulant intended to provide symptom control of ADHD in adults for up to 16 hours with one daily dose. Following receipt of this approvable letter, Shire is evaluating its options related to SPD465.

Shire submitted a New Drug Application for SPD465 on July 21, 2006<SUP>1</SUP>. If approved, SPD465 will be a treatment option for adults with ADHD and part of Shire’s overall ADHD portfolio.

I have been taking Vyvanse for almost a year now. ( i got in on a trial) and found that the 30mg didn't do much for me. the 50mg made me very drowsy in the afternoon. I have been on the 70 mg and it has worked great for me. ( I have also lost 40 pounds!!! YEAH!! Which I needed to lose)
The only down side is if I forget to take it in the morning and I take it after 9 or 10 , I have a very difficult time going to sleep at night.

Also, my son has started taking it and it does last longer the the Adderall XR he was on. When he was on the adderall, we struggled in the late afternoons and evenings. Now, i can really tell when the medication has worn off around 7 or so.

I have been taking Vyvanse for almost a year now. ( i got in on a trial) and found that the 30mg didn't do much for me. the 50mg made me very drowsy in the afternoon. I have been on the 70 mg and it has worked great for me. ( I have also lost 40 pounds!!! YEAH!! Which I needed to lose)
The only down side is if I forget to take it in the morning and I take it after 9 or 10 , I have a very difficult time going to sleep at night.

Also, my son has started taking it and it does last longer the the Adderall XR he was on. When he was on the adderall, we struggled in the late afternoons and evenings. Now, i can really tell when the medication has worn off around 7 or so.

So... how, long would you say, are the effects of the medication noticeable? 12 hours?

Can you compare it to other medications? Have you taken any others before Vyvanse?

It's great that you can help to share your unique experience with the rest of us! :)