Navigation Links
FDA Advisory Committee Votes Unanimously to Recommend Approval of Tetrabenazine for Chorea Associated With Huntington Disease

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

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:
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, Vitalalert ... Organizations, One Beat ” campaign. The partnership between the two groups began in 2014 ... MAP International’s cause. , MAP International was founded in 1954 and is an international ...
(Date:11/25/2015)... ... ... On November 25, 2015, officials of Narconon Arrowhead , the drug rehabilitation ... new cutting edge recovery program that has been 50 years in the making. ... with the purpose to free addicts from the symptoms and negative behaviors of addiction. ...
(Date:11/25/2015)... ... ... Smiles by Stevens is pleased to announce the addition of Botox® for ... aware of the benefits of Botox® in the treatment of moderate facial wrinkling, few ... and pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) disorder, and Bruxism ...
(Date:11/25/2015)... ... November 25, 2015 , ... In an ongoing Clinical Study conducted by an ... IL, UV Angel is evaluating the efficacy of its product and its disinfection protocol. ... 30 beds) from May 2014 through October 2015 at a 360-bed, acute-care, academic medical ...
(Date:11/25/2015)... Spring, Md (PRWEB) , ... November 25, 2015 ... ... Pulmonary Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups responsible ... history of this disease. The Periwinkle Pioneers, nominated by the public, will receive ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... 2015 Kitov Pharma ceuticals ... a biopharmaceutical company focused on the development of therapeutic ... today announced the closing of its previously announced underwritten ... ), each representing 20 ordinary shares of the Company, ... ADSs and warrants were issued in a fixed combination ...
(Date:11/25/2015)...  Today AVACEN Medical announced the issue of United States patent No. ... ". This patent shields the company,s AVACEN 100 dry heat therapy medical device and specific methods ... Photo - ... ... ...
(Date:11/25/2015)... , Nov. 25, 2015 USP 800 ... drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, ... technicians). The chapter also covers all entities which ... pharmacies, hospitals, other healthcare institutions, patient treatment clinics, ... --> --> What is ...
Breaking Medicine Technology: