http://www.shire.com/shire/NewsAndMedia/PressReleases/showShirePress.jsp?ref=865&tn=3&m1=8&m2=13

FDA Approves Additional Dosage Strengths of Shire’s ADHD Treatment VYVANSE™ (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients


To Date, More than 500,000 Total Prescriptions Have Been Dispensed for VYVANSE 30, 50 and 70 mg

03 Jan 2008 - PHILADELPHIA — January 3, 2008 –– Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for three additional dosage strengths for the attention deficit hyperactivity disorder (ADHD) treatment, VYVANSE™ (lisdexamfetamine dimesylate). Shire expects the three additional dosage strengths of 20 mg, 40 mg and 60 mg will be available in retail pharmacies in the second quarter of 2008 to supplement the existing 30 mg, 50 mg and 70 mg dosage strengths currently available in pharmacies throughout the country.

“Shire is pleased that physicians will soon have the benefit of a wider range of VYVANSE dosage strengths which they can prescribe to help manage the ADHD symptoms of their patients,” said Matt Emmens, Chief Executive Officer of Shire Pharmaceuticals. “In its first six months of availability, more than 500,000 VYVANSE prescriptions have been dispensed, indicating that physicians see VYVANSE as an effective treatment option for their patients.”

Dose titration, the process of incrementally increasing or decreasing the dose of a medication, is a widely used method in clinical practice to help achieve optimal efficacy and tolerability for each patient. The option of having dosage strengths with smaller increments allows for a more gradual titration of medication and may help the physician tailor the treatment for each individual patient.

“Shire has also experienced early success with managed care coverage for VYVANSE, which is now preferred on three of the five largest national plans. According to available national data, more than 85 percent of lives in the United States are covered for VYVANSE in Tier 3 or better,” added Emmens. “We are optimistic that the formulary coverage for VYVANSE will continue to improve as we move into 2008.”

VYVANSE is currently approved in the United States for the treatment of ADHD in children aged 6 to 12 years. A Supplemental New Drug Application (sNDA) for VYVANSE for the treatment of ADHD in adults is currently under review by the FDA.

VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of VYVANSE to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in normal GI transit times.

Additional information about VYVANSE and Full Prescribing Information are available at www.vyvanse.com.

I think that's definitely a good thing (and something that should have been implimented from the very beginning). These meds are too "touchy" ad far as small differenced in doses reacting quite differently. I've thought all along that the limitation of only having those 3 strengths available was ridiculous and would make it diffucult for many to get the proper dose worked out.

Good news, IMO.

I'm also really glad. Though I can make do with the current, now that I've gotten used to pouring small amounts of a second cap into a water bottles, it would be great to have a dose I could take in whole pill form as easily as my after-breakfast multivitamin.

Does anyone know how accurate these projected releases are in the pharmaceutical world? I know when I was more heavily into PC hardware and console games, these announced windows were often missed by months at a time. I'd like to switch over to 40mg before school ends around the 1st of May.

Oh, hey, just last Friday I talked with my psych. about changing my current prescription (30mg Vyvanse x 1, 5mg Adderall IR x 1). I asked him about a few different things, decided they weren't for me , and asked him pretty much the same question I posed above (about when in quarter 2 they might be released). He used some program on his desktop and found out the new dosages have already been released! You might have to wait a few days for your pharmacy to order them, but they're definitely out.

Now I'm trying 20mg Vyvanse x 2, and the insurance co-pay didn't even go up. For some reason I thought price was per-pill. This is pretty awesome news, and now I'd have to say I'm pretty satisfied with the way Shire has handled this in pretty much every way. Price relative to generic d,l-amp salts and generic d-amp is the only downside I've seen, with respect to what I know about ADD medications as a whole.

Oh, hey, just last Friday I talked with my psych. about changing my current prescription (30mg Vyvanse x 1, 5mg Adderall IR x 1). I asked him about a few different things, decided they weren't for me , and asked him pretty much the same question I posed above (about when in quarter 2 they might be released). He used some program on his desktop and found out the new dosages have already been released! You might have to wait a few days for your pharmacy to order them, but they're definitely out.

Now I'm trying 20mg Vyvanse x 2, and the insurance co-pay didn't even go up. For some reason I thought price was per-pill. This is pretty awesome news, and now I'd have to say I'm pretty satisfied with the way Shire has handled this in pretty much every way. Price relative to generic d,l-amp salts and generic d-amp is the only downside I've seen, with respect to what I know about ADD medications as a whole.

When are you taking the 20mg x 2? I'm guessing one in the morning and then one in mid afternoon. How is that working out for you?

The reason I ask is that I am currently on 30mg and am finding that it leaves my system way too early. If I take the pill at say 8am, by 2pm I am somewhat crashing. Not a hard crash the way I hear Aderall is (I've never taken it), but it just makes me have quite low energy and not much desire to do anything at. Obviously this isn't so good :) if I'm still trying to be productive. I know my doc is somewhat concerned about not being able to sleep taking a pill later in the day. But, I never had that side effect. I'm able to sleep know problem (even when I've experimented and taken a half dose at 4-5pm).

When are you taking the 20mg x 2? I'm guessing one in the morning and then one in mid afternoon. How is that working out for you?

The reason I ask is that I am currently on 30mg and am finding that it leaves my system way too early. If I take the pill at say 8am, by 2pm I am somewhat crashing. Not a hard crash the way I hear Aderall is (I've never taken it), but it just makes me have quite low energy and not much desire to do anything at. Obviously this isn't so good :) if I'm still trying to be productive. I know my doc is somewhat concerned about not being able to sleep tak ing a pill later in the day. But, I never had that side effect. I'm able to sleep know problem (even when I've experimented and taken a half dose at 4-5pm).

Wow, we're pretty alike in that respect. I used to take my 30mg sometime before 7:30AM, and sometime during my 12:30-1:45 PM class I'd start to feel a little depressed or low-energy.

How I space the two 20mg doses just depends on my class schedule that day. MWF, when I have classes from only 9-11AM, I take one before a small breakfast around 8:30 and another right after lunch (for nutrition and to delay absorption even more) at around 11:30. This'll give me attention through my classes and a comfortable, sustained span of many hours during which I can get a lot of studying done uninterrupted. This way I get a total of around 8-9 hours of effective medication vs. the previous 8-9 hours total (with 4-6 prime hours), with only 1/3 more medicine. However, I realize many people don't have the opportunity to micromanage as much as I like to.

Depending on what you're using it for, the 20mg initial dosage might not be enough for you. The first couple hours after my initial dose are noticeably less strong than those of the 30mg, but I don't need as much for attending lecture and taking notes as I do for reading and completing assignments. Like you, I never had and still don't have any problem with sleep. The second mid-afternoon (sometime 12A-2P) dose I take TR only keeps me awake if I'm occupying myself with something - when I try to clear my mind (remarkably easy on meds) I can actually get to sleep easier!

Wow, we're pretty alike in that respect. I used to take my 30mg sometime before 7:30AM, and sometime during my 12:30-1:45 PM class I'd start to feel a little depressed or low-energy.

How I space the two 20mg doses just depends on my class schedule that day. MWF, when I have classes from only 9-11AM, I take one before a small breakfast around 8:30 and another right after lunch (for nutrition and to delay absorption even more) at around 11:30. This'll give me attention through my classes and a comfortable, sustained span of many hours during which I can get a lot of studying done uninterrupted. This way I get a total of around 8-9 hours of effective medication vs. the previous 8-9 hours total (with 4-6 prime hours), with only 1/3 more medicine. However, I realize many people don't have the opportunity to micromanage as much as I like to.

Depending on what you're using it for, the 20mg initial dosage might not be enough for you. The first couple hours after my initial dose are noticeably less strong than those of the 30mg, but I don't need as much for attending lecture and taking notes as I do for reading and completing assignments. Like you, I never had and still don't have any problem with sleep. The second mid-afternoon (sometime 12A-2P) dose I take TR only keeps me awake if I'm occupying myself with something - when I try to clear my mind (remarkably easy on meds) I can actually get to sleep easier!


Thanks for the info. Glad it's working out for you.

My doc wanted me to try 1/3 of my dose (which is 10mg) and the remaining 2/3 (20mg) later in the day. Unfortunately, I find the 10mg to be pretty much useless. I'm going to have to see what my doc suggests.

On another note, with sleep, I don't actually have a problem falling asleep once I get in bed. The problem for me has always been getting into bed. When I have that time at the end of the night, there are always so many things I "want" to do or that interest me. It actually takes a bit of willpower for me to get into bed. Now that I am on medication, I am doing somewhat better. But, the meds have worn off and it is still something I struggle with.

Should be pretty quick. They are not changing the drug, just changing the amount of it in capsules. Capsules are much faster than retooling for pills.

I have been trying to get my son 20 mg for a couple of weeks now and still can't get it. The pharmacy said that it is on back order and for me to just check back from week to week. Why is it taking so long.