Navigation Links
FDA Advisory Committee Votes Unanimously to Recommend Approval of Tetrabenazine for Chorea Associated With Huntington Disease
Date:12/6/2007

WASHINGTON, Dec. 6 /PRNewswire/ -- An advisory committee to the U.S. Food and Drug Administration (FDA) today voted unanimously to recommend the approval of tetrabenazine, which would be the first drug approved in the United States to treat chorea associated with Huntington disease (HD).

"The advisory committee's support of tetrabenazine represents an important advancement for Huntington disease patients, caregivers, advocates and physicians who treat this devastating disease," said George F. Horner III, president and chief executive officer of Prestwick. "We are committed to continuing to work with the FDA to secure full approval of tetrabenazine."

While the FDA is not required to follow the advice of its advisory committees, they generally do.

HD is a devastating neurodegenerative disease that causes progressive movement disorders, cognitive dysfunction and behavioral changes, that is ultimately a fatal condition. Chorea is characterized by excessive, involuntary and repetitive movements which are the most visible and dangerous manifestations of Huntington disease.

"Patients and physicians do not have any approved treatments to alleviate this disorder or any aspect of Huntington disease," said Frederick Marshall, MD, chief of the geriatric neurology unit at the University of Rochester, who presented data on behalf of Prestwick. "We are hopeful that the FDA will adhere to the recommendations made by the committee to quickly bring tetrabenazine to the patients for whom we care."

Chorea affects over 30,000 Americans, interfering with their ability to perform activities of daily living, including dressing, bathing and caring for themselves. Currently, there are no treatments to stop or reverse the onset or progression of HD and there are no FDA-approved drugs for chorea.

About Tetrabenazine

Tetrabenazine is an investigational compound for the treatment of chorea associated with HD. A highly selective and reversible centrally-acting dopamine depleting drug, tetrabenazine works by inhibiting a molecule known as VMAT2 (vesicular monoamine transporter 2).

Adverse events reported with tetrabenazine, most of which were addressed by titrating down the dose, included depression, akathisia, parkinsonism and sedation. Tetrabenazine's effects are largely reversible and manageable.

The FDA has issued an approvable letter for the compound. Tetrabenazine has been designated as an "orphan drug" by the FDA and has been granted "fast track" status.

About Prestwick

Prestwick Pharmaceuticals, a privately-held pharmaceutical company headquartered in Washington, is currently managing a portfolio of pipeline product candidates being studied for CNS conditions with significant unmet needs, including Huntington's disease, Parkinson's disease, restless legs syndrome, schizophrenia, autism, Alzheimer's disease and sleep apnea. For more information, go to http://www.prestwickpharma.com


'/>"/>
SOURCE Prestwick Pharmaceuticals
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Genaera Announces Formation of Scientific Advisory Board for Obesity Drug Candidate Trodusquemine (MSI-1436)
2. China Holdings Appoints Ronald Shon Chairman of Advisory Board to Its Wholly-Owned Subsidiary China Power, Inc.
3. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
4. Patient Safety Authority Board of Directors Names Infection Advisory Panel
5. Broker a Suite of Research & Advisory Services to Enhance Human Resources
6. Lynn Clark Callister, National Leader in Maternal-Child Health Nursing, Joins March of Dimes Advisory Council
7. MaxLife Fund Corp. appoints Daniel E. Kahan, to its Advisory Board
8. Delta Dental Plans Association Forms National Scientific Advisory Committee
9. Alter+Care Creates the Advisory Board
10. Patient Safety Authority Releases Advisory Focusing on Common Causes of Medication Errors
11. Susan G. Komen for the Cure Appoints Dr. Amelie G. Ramirez to Scientific Advisory Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... ... December 08, 2016 , ... ... (WCRI) officially opened registration today for its 33rd Annual Issues & Research ... . , The theme of the conference is “Persistent Challenges and New Opportunities: ...
(Date:12/8/2016)... ... 08, 2016 , ... CURE Media Group, the nation’s leading digital and print ... Upstage Lung Cancer in efforts to combat lung cancer, announced CURE Media Group President ... “CURE Media Group is honored to team up with Upstage Lung Cancer in order ...
(Date:12/8/2016)... (PRWEB) , ... December 08, ... ... Presence Suite 10.2 version gives development continuity to its innovative Unified Instance ... channels management capacity. In addition, this new version optimizes the unattended auto-dialing ...
(Date:12/8/2016)... , ... December 08, 2016 , ... ... after surgery as possible. With this in mind, SIGVARIS has created a new ... blood clot) during bed rest and provide the benefits of graduated compression when ...
(Date:12/8/2016)... ... December 08, 2016 , ... The ... offices headquartered in Jefferson County, is announcing the launch of a charity drive ... The number of homeless women and children in Birmingham has grown steadily since ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... , Dec. 8, 2016  Valeant Pharmaceuticals ... TSX: VRX) ("Valeant") today announced positive results from ... study to assess the safety and efficacy of ... treatment of plaque psoriasis. Within ... with moderate to severe psoriasis, IDP-118 showed statistical ...
(Date:12/8/2016)... FRISCO, Texas , Dec. 8, 2016 /PRNewswire/ ... new program that brings leading-edge laboratory services and ... the United States , allowing more doctors ... and health care management solutions. Logo ... Hospital systems, under pressure to ...
(Date:12/8/2016)... , December 8, 2016 Information products ... metrics in Scopus , the world,s largest abstract ... access to comprehensive metrics for journals from over 5,000 publishers. The ... which journals to subscribe to and when to adjust a journal,s ... , , ...
Breaking Medicine Technology: