View Full Version : FDA approves Shire's ADHD drug Vyvanse


Andrew
02-24-07, 07:02 PM
By ANDREW BRIDGES, Associated Press Writer Fri Feb 23, 8:13 PM ET

WASHINGTON - A new amphetamine-based drug to treat attention deficit hyperactivity disorder won federal approval Friday. It's harder to abuse than older stimulants, the manufacturer says.

The Food and Drug Administration approved Vyvanse, also known as lisdexamfetamine, agency spokeswoman Susan Cruzan said. The drug is made by Shire PLC.

Shire hopes the drug will extend its lucrative ADHD franchise once its top-selling Adderall XR begins facing competition from lower-priced generic versions in 2009. Shire plans to move patients from the older to the newer drug at the time, company spokesman Matt Cabrey said this week.

Shire said it tried to limit the drug's potential for misuse. It tested the drug on adults with a history of abusing stimulants to assess its "likeability." Results suggest the drug delays the onset and limits the intensity of amphetamine-like effects, the company said.

Vyvanse works by gradually releasing its active ingredient, d-amphetamine, after the drug has been swallowed and comes into contact with enzymes in the digestive tract.

Unless it's swallowed, Vyvanse remains inactive. Shire believes that will curtail its potential for abuse by users who snort or inject crushed pills.

Despite those measures, the Drug Enforcement Administration has proposed making Vyvanse a Schedule II drug, a class that includes cocaine, methadone, methamphetamine and other drugs with a high potential for abuse.

Other ADHD medicines, including Adderall and Ritalin, also are Schedule II drugs.

Vyvanse's label will bear a "black-box" warning, the government's strongest, Cruzan said. Details were not immediately available.

The label of Adderall XR bears a warning because of safety concerns related to amphetamine abuse as well as the risk of sudden death in patients with heart defects.

FDA approval of Vyvanse came the same week that the agency asked all manufacturers of ADHD drugs to warn patients and their parents of mental and heart problems associated with use of the medicines.

Britain's Shire said earlier this month it would spend roughly $2.6 billion to buy New River Pharmaceuticals Inc., the Radford, Va., company that originally developed Vyvanse.

http://news.yahoo.com/s/ap/20070224/ap_on_he_me/adhd_drug;_ylt=ApMYb7Vz_zN3Xn7uNEKpBsbMWM0F

netsavy006
02-24-07, 10:26 PM
Wow. Good information there Andrew. One thing I don't like in the article, is the fact that the Adderall is going to be stopped. There are many people out there who may not tolerate this new drug and tolerate Adderall better. What are these people going to do if Adderall works for them and this drug doesn't?

Andrew
02-24-07, 10:34 PM
I don't see anywhere in the article that Shire PLC plans on stopping making Adderall?

netsavy006
02-24-07, 10:36 PM
Shire plans to move patients from the older to the newer drug at the time
Why would Shire do this if they weren't planning to stop making adderall?

Andrew
02-24-07, 10:38 PM
Because...Shire hopes the drug will extend its lucrative ADHD franchise once its top-selling Adderall XR begins facing competition from lower-priced generic versions in 2009.

netsavy006
02-24-07, 10:39 PM
Even so, I'd still like the adderall xr to still be available.

Andrew
02-24-07, 10:46 PM
I think perhaps you're missing the point of the article. Shire's goal, as stated in the article, isn't to discontinue Adderall xr, but since other companies can start making generic Adderall XR-type meds in 2009, (and Shire will likely lose sales of their brand-name Adderall XR to those companies selling the generic versions) they're looking to offset their income by moving patients to Vyvanse , a med they can charge full price for.

SamCurt
02-25-07, 05:38 AM
For the time being Shire has granted exclusing generic license for Adderall XR to Barr.

SamCurt
02-25-07, 09:39 AM
The complete Shire press release, all the works:

23 Feb 2007 - Basingstoke, U.K., Philadelphia, PA and Radford, VA – FEBRUARY 23, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) and its collaborative partner New River Pharmaceuticals Inc. (NASDAQ: NRPH) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VYVANSE (lisdexamfetamine dimesylate, formerly known as NRP104), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

On February 20, 2007 Shire and New River announced an agreement whereby Shire will acquire New River for approximately $2.6 billion in an all cash transaction unanimously recommended by the Boards of both companies. The transaction is the subject of another press release issued February 20, 2007.

VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

Randal J. Kirk, New River’s Chairman and Chief Executive Officer, remarked, “VYVANSE’s approval signals a new era in the treatment of ADHD. Upon product launch, patients will have a novel treatment option combining the effectiveness of a stimulant – long considered the gold standard in ADHD medicines – with other potential benefits.”

The FDA has proposed that VYVANSE be classified as a Schedule II controlled substance. This proposal was submitted to and accepted by the U.S. Drug Enforcement Administration (DEA). A final scheduling decision is expected from the DEA following a 30-day period for public comment. Once VYVANSE receives final scheduling designation, the label will be available. Pending final scheduling designation, product launch is anticipated in Q2 2007. VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.1

New River developed VYVANSE as a new ADHD medication designed to provide lower potential for abuse, in which d-amphetamine is covalently linked to l-lysine, a naturally occurring amino acid. The combination is rapidly absorbed from the gastrointestinal tract and converted to d-amphetamine, which is responsible for VYVANSE’s activity.

Joseph Biederman, MD, director of Pediatric Psychopharmacology at Massachusetts General Hospital, was lead investigator on the pivotal clinical studies testing lisdexamfetamine dimesylate for the treatment of ADHD. These large multi-site studies showed that the drug significantly reduced ADHD symptoms throughout the day with a predictable tolerability profile. “Our studies showed that this next-generation stimulant medication's unique chemical profile offers an option for physicians and their patients in the treatment of ADHD, with outstanding efficacy and duration of action” said Dr. Biederman.

Additional information about VYVANSE and other Shire treatments for ADHD is available at www.ShireADHDTreatments.com.


VYVANSE Significantly Controls ADHD Symptoms
Data from phase II and phase III clinical trials demonstrated statistically significant improvements in ADHD symptoms for patients aged 6 to 12 years treated with VYVANSE compared to patients treated with placebo. These studies demonstrated that all doses of VYVANSE (30 mg, 50 mg and 70 mg) provided significant efficacy at all time points tested, including 6pm.2

In the phase II, analog classroom study, patients demonstrated significantly improved behavior when receiving either VYVANSE or ADDERALL XR® (mixed salts of a single-entity amphetamine product) as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment rating scale, a standardized, validated classroom assessment tool used for evaluating the behavioral symptoms of ADHD.3 Both treatments resulted in significantly improved behavior versus a placebo (P <.0001, for both).4 Patients also demonstrated significantly improved academic productivity with both treatments, compared to placebo (P <.0001 for both medications) as measured by Permanent Product Measure of Performance (PERMP), an age-adjusted collection of math problems that measures a child’s ability to pay attention and stay on task as demonstrated by an increase in the number of attempted and successfully completed problems.4

In the phase III, randomized, double-blind placebo-controlled study, all three doses of VYVANSE demonstrated significant improvements in ADHD Rating Scale (ADHD-RS-IV) scores compared with placebo (P <.0001) after four weeks of once-daily treatment. 5 ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD in children and for assessing their response to treatment.6,7 This scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the APA’s Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision®, a publication of the American Psychiatric Association. 8

Additionally, in a study presented in October at a major scientific meeting, VYVANSE yielded a 60 percent improvement in the primary rating scale scores for symptoms of ADHD in children aged 6 to 12 years who received six months of treatment in an open-label phase III study. Results also demonstrated that at 6 months, 95 percent of children taking VYVANSE produced a “much improved” or “very much improved” rating on the Clinical Global Impressions – Improvement score.9


About VYVANSE and ADDERALL XR
Tell your doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform your doctor immediately if you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.

VYVANSE or Adderall XR should not be taken by patients who have advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.

Tell your doctor before using VYVANSE or Adderall XR if you or your child are being treated for or have symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; have abnormal thoughts or visions, hear abnormal sounds, or have been diagnosed with psychosis; have had seizures or abnormal EEGs; have or have had high blood pressure; exhibit aggressive behavior or hostility. Tell your doctor immediately if any of these conditions or symptoms develop while using VYVANSE or Adderall XR.

Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.

VYVANSE and Adderall XR were generally well tolerated in clinical studies. The most common side effects in studies of VYVANSE included: children - decreased appetite, difficulty falling asleep, stomachache, and irritability. The most common side effects in studies of Adderall XR included: children - decreased appetite, difficulty falling asleep, stomachache, and emotional lability; adolescents - loss of appetite, difficulty falling asleep, stomachache, and weight loss; adults - dry mouth, loss of appetite, difficulty falling asleep, headache, and weight loss.

Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics and Tourette’s syndrome have been associated with use of drugs of this type. Tell your doctor if you or your child have blurred vision while taking VYVANSE or Adderall XR.


The Collaboration Agreement
In January 2005, New River Pharmaceuticals signed a collaborative agreement with Shire to develop and commercialize VYVANSE. Details on the collaboration agreement are available in previous filings with the U.S. Securities and Exchange Commission.



Planned Acquisition Additional Information
The tender offer described in this press release has not yet commenced, and this press release is neither an offer to purchase nor a solicitation of an offer to sell New River common stock. Investors and security holders are urged to read both the tender offer statement and the solicitation/recommendation statement regarding the tender offer described in this report when they become available because they will contain important information. The tender offer statement will be filed by a subsidiary of Shire with the Securities and Exchange Commission (SEC), and the solicitation/recommendation statement will be filed by New River with the SEC. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed by Shire or New River with the SEC at the website maintained by the SEC at www.sec.gov. The tender offer statement and related materials may be obtained for free by directing such requests to Shire at Hampshire International Business Park, Chineham, Basingstoke, Hampshire, England, RG24 8EP, attention: Investor Relations. The solicitation/recommendation statement and such other documents may be obtained by directing such requests to New River at 1881 Grove Avenue, Radford, Virginia 24141, attention: Director of Corporate Communications.

netsavy006
02-25-07, 03:53 PM
...they're looking to offset their income by moving patients to Vyvanse , a med they can charge full price for.
Do other Pharmicutical companies do this?

Andrew
02-25-07, 04:15 PM
Do other Pharmicutical companies do this?

Yup...I would imagine they do all the time.

Matt S.
02-25-07, 07:11 PM
They are making a 16 hour adderall

HighFunctioning
02-25-07, 07:58 PM
Well, based on what most people experience with the current Adderall, I'd bet (no, not really) that it will last probably somewhere from 9-12 hours in reality (three types of beads instead of two).

SamCurt
02-26-07, 07:18 AM
Yup...I would imagine they do all the time.Yes, in the case of Celexa vs Lexapro, or Claritin vs Clarinex. The latter is a stereoisomer of the former which has newer patents.

netsavy006
02-27-07, 10:20 AM
Does anybody know an expected date for the release of this med to the general public?

SamCurt
02-27-07, 11:15 AM
I think I mentioned elsewhere that Shire's to release it in 2Q.

netsavy006
02-27-07, 01:58 PM
Ok. Thanks for the info.