Love Maharashtra? Then you wil love Marathikatta!
Home Politics Religion Media Biz Society Tech Travel Books Intl. Autos Automobiles
                    Movies   Aviation   Pharma   About Us   Feedback   Links
XENAZINE FOR TREATMENT OF CHOREA IN HD PATIENTS
 


Prestwick gets approvable letter for Xenazine for treatment of chorea with HD

BY OUR PHARMA CORRESPONDENT
April 4, 2006

Xenazine (tetrabenazine), which is under review for the treatment of chorea associated with Huntington's disease (HD), has been received an approvable letter from the US Food and Drug Administration (FDA). 

The Washington, DC based drug maker, Prestwick Pharmaceuticals said the approvable letter specifies conditions that the company must meet prior to obtaining approval to market Xenazine in the U.S. In this letter, the FDA also indicated its intent to discuss the company's New Drug Application (NDA) at a public meeting of the Peripheral and Central Nervous System Advisory Committee. 

Xenazine is a highly selective and reversible dopamine depletor that works by inhibiting vesicular monoamine transporter 2 (VMAT2). Xenazine is the first product for which an NDA has been filed in the U.S. for treatment of chorea associated with Huntington's disease.

Chorea, a debilitating feature of a number of neurological diseases, is characterized by excessive, involuntary, and repetitive movements, which may involve the face, limbs, or the entire body. In HD, it is the result of overactivity of the neurotransmitter dopamine. The FDA designated tetrabenazine an orphan product for Huntington's disease because it affects only an estimated 30,000 patients in the U.S.

The FDA also designated tetrabenazine a fast track product because there are no other drugs available in the U.S. to treat chorea. Xenazine is approved in 8 markets outside of the U.S. and is currently marketed by Prestwick Pharmaceuticals Canada as Nitoman. 

Prestwick Pharmaceuticals, Inc. is a product-based specialty pharmaceutical company engaged in the development and marketing of small molecule drugs for chronic diseases of the central nervous system (CNS). The company has rights to a portfolio of five product candidates obtained under licenses from third parties that are being studied for a range of CNS conditions with significant unmet needs, including Huntington's disease, Parkinson's disease, restless legs syndrome, schizophrenia, autism, Alzheimer's disease, and sleep apnea. Tetrabenazine, the company's lead product candidate, was licensed for marketing in the U.S. and Canada by Cambridge Laboratories (Ireland), Limited , which has worldwide rights to the product. Cambridge markets the product itself in the UK and Eire (Ireland), and through marketing partners in European and other markets.

More related stories from Pharma


Healing prayers no cure for the ill, says study

Pulmonary hypertension drug PulmoLAR in human trial

Pharma markets in China, Korea, Mexico, Russia & Turkey gather pace

Pfizerís anxiety drug Lyrica gets EU nod

Asymmetrical breasts: A presage to cancer?

Dream to eradicate polio still far off

GlaxoSmithKline loses fluticasone case

Able files recast plan with bankruptcy court

Ranbaxy in pact with Zenotech on cancer drugs

Lupin and Aspen to form JV on TB drugs

Blood cancer drug Ceflatonin gets orphan drug status

Bangladesh to set up API park; to export drugs worth Tk 8.50 cr to Burma

Wockhard Limited: A profile
Cipla Ltd company profile

 

 

 

Auto news for auto freaks! iDrive.in
DWS community! / Cricket blog

 

Latest Stories in Pharma

 Vertex commences phase II studies for Aurora kinase inhibitor VX-680

GlaxoSmithKline starts H5N1 avian flu vaccine trials in Germany, Belgium

Novartis acquires rights for two drug leads

Serono plans major acquisitions

Samaritan to sell Amphocil in Greece

HIV infection cases fall in South India

Flu drug: Erimos, NC State University seek patent for EM-1421

HollisterStier inks pact with Prism Pharma on cardiovascular drug PM101

Erbitux approved for head and neck cancer in Europe

EPIX Pharmaceuticals merges with Predix

Avanir's involuntary emotional expression disorder (IEED) drug Neurodex gets priority review

 Death of women raises alarm on abortion pillís safety

Prestwick gets approvable letter for Xenazine for treatment of chorea with HD

Nexavar - Kidney cancer drug gets Swiss nod

Anti-rejection drug Prograf approved in US

 

Latest Stories in Pharma

Archived Pharma stories

 

Latest updates    Contact Us - Feedback    About Us