Navigation Links
XENAZINE(R) (Tetrabenazine) Approved by FDA for Patients with Chorea Associated with Huntington's Disease
Date:8/15/2008

WASHINGTON, Aug. 15 /PRNewswire/ -- Prestwick Pharmaceuticals, Inc., a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved XENAZINE(R) (tetrabenazine) for the treatment of chorea associated with Huntington's disease (HD). XENAZINE is the first and only FDA-approved treatment for any symptom of HD and is expected to be available later this year.

"Until today, physicians and patients had no FDA-approved treatments for Huntington's disease," said Fred Marshall, M.D., chief of the geriatric neurology unit at the University of Rochester. "Within a few months, for the first time, physicians will be able to offer these critically-ill patients a safe and effective medication to treat their chorea."

A double-blind, placebo-controlled, Phase 3 study found that XENAZINE significantly reduced patients' chorea burden, improved global outcome scores, and was generally safe and well tolerated. XENAZINE will be marketed under an FDA-approved Risk Evaluation and Mitigation Strategy to decrease the risk of depression and suicidal ideation that may be associated with the drug, and are often pre-existing conditions in Huntington's disease patients.

In December 2007, patients, advocates, and caregivers spoke in favor of approving XENAZINE at a meeting of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee. The committee voted 11-0 to recommend approval of the drug.

"We are pleased that the FDA has approved XENAZINE, the first medication for the Huntington's disease patients and physicians who are in desperate need of a treatment," said George F. Horner, III, president and chief executive officer of Prestwick. "The approval of XENAZINE is a huge advancement for the HD community, and we thank them for their contributions in helping to make this important product available in the United States."

XENAZINE has been available in a number of countries in Europe for more than 30 years.

About Huntington's Disease

Affecting an estimated 30,000 Americans, HD is a devastating neurodegenerative disease that causes progressive movement disorders, cognitive dysfunction and behavioral changes and is ultimately a fatal condition. Chorea is the most common symptom, affecting approximately 90% of HD patients, and is characterized by excessive, involuntary and repetitive movements, which are the most visible and dangerous manifestations of HD and interfere with patients' abilities to perform activities of daily living, including dressing, bathing and caring for themselves. For more information about HD, please visit http://www.hdfoundation.org or http://www.hdsa.org.

About XENAZINE (tetrabenazine)

XENAZINE is indicated for the treatment of chorea associated with Huntington's disease. A selective and reversible centrally-acting dopamine depleting drug, XENAZINE works by inhibiting a molecule known as VMAT2 (vesicular monoamine transporter 2). XENAZINE has been designated as an "orphan drug" by the FDA and will have seven years market exclusivity in the United States. Full prescribing information will be available at http://www.prestwickpharma.com in the near future.

Important Safety Information

The most frequent and serious adverse events seen with tetrabenazine are somnolence/sedation and insomnia, respectively. Adverse events reported with XENAZINE included depression, akathisia, parkinsonism and sedation. XENAZINE's effects are largely reversible and manageable.

About Prestwick

Prestwick Pharmaceuticals, a privately-held pharmaceutical company headquartered in Washington, DC, is currently managing product candidates for CNS conditions with significant unmet needs, including Huntington's disease, schizophrenia, and sleep apnea. For more information, go to http://www.prestwickpharma.com.


'/>"/>
SOURCE Prestwick Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. $52.5 Million Settlement Against Sepracor Inc. Approved
2. FDA Cracks Down on Unapproved Cough Medicines
3. Video: New FDA-Approved Sun Protectant Saves Skin All Year Round
4. Optometry-Backed Vision Care for Kids Act Approved by U.S. House
5. Voltaren(R) Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis
6. A fresh look at existing therapies: Researchers explore ways to teach approved drugs new tricks
7. Barrs Generic Version of Estrostep(R) Fe Tablets Approved
8. PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy
9. Pennsylvania American Waters Rate Case Approved
10. RNs Statement on Death of Nataline Sarkisyan: CIGNA Should Have Listened to her Doctors and Approved the Transplant a Week Ago
11. Hiemstra Approved to Manufacture Medical Devices in New CER
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2017)... ... July 24, 2017 , ... A CDC study shows that, although people are taking ... (ages 18 to 29), had at least one case of sunburn within the past year. ... causes people to ignore the issue. However, only recently have people become conscientious of the ...
(Date:7/24/2017)... ... ... Anyone who uses scales know they have limits; a small kitchen scale ... scale to dispense medication. The first example is an issue of capacity, while the ... important to have the right balance for the process. METTLER TOLEDO’s new white paper, ...
(Date:7/24/2017)... ... July 24, 2017 , ... Sharon Kleyne, host of the nationally ... on VoiceAmerica sponsored by Nature’s Tears® EyeMist® recently talked on the air about an ... China. , The article by Zidor Aldama described the situation in which Chinese children ...
(Date:7/24/2017)... ... 2017 , ... Paul Vitenas, MD, FACS is excited to report that he ... attend Allergan’s recent meeting with their Plastics Advisory Board. As one of the top ... bringing a newly defined structure to the aesthetics market. Dr. Vitenas , along ...
(Date:7/24/2017)... ... July 24, 2017 , ... The Magic Wand® Rechargeable, the ... for favorite sex toy. Created in collaboration with website Kinkly.com, the award was ... voted. The Magic Wand Rechargeable won in stiff competition from brands such as ...
Breaking Medicine News(10 mins):
(Date:7/12/2017)... 12, 2017 CarpalAID is a revolutionary new product that ... Carpal tunnel syndrome affects more than 8 million people ... rate of men. The common methods of treating CTS are painful ... hand braces or gloves. ... CarpalAID is a clear patch worn on the ...
(Date:7/11/2017)... ROCKVILLE, Md. , July 11, 2017  The ... had estimated revenues of approximately $394.1 million in 2016.  ... a trend of solid growth, in particular as a ... oncology clinical practice, and the recent introduction of a ... the need for less-invasive testing of tumor biomarkers to ...
(Date:7/10/2017)...  US medical equipment and supply demand is forecast ... Medical Equipment & Supplies: United States , ... increases in demand for medical services – driven in ... supported by gains in disposable personal income – will ... introductions will also drive sales as providers and patients ...
Breaking Medicine Technology: