Prestwick Drug Looks Good for Huntington's
Posted on: Tuesday, 14 February 2006, 15:01 CST
Prestwick Pharmaceuticals said Tuesday a new study shows its potential drug tetrabenazine works against Huntington's disease.
The company said results of a phase 3 clinical trial -- appearing in the Feb. 14 issue of the Journal of Neurology -- show the drug taken at doses up to 100 mg per day significantly improved clinical outcomes and reduced symptoms of chorea, a condition linked to Huntington's disease.
The study also showed the investigational drug is generally safe and well tolerated.
If the drug is approved, Prestwick said it would market the product under the brand name Xenazine.
Chorea -- for which Prestwick said there are no currently approved treatments -- is a neurological disorder that causes incessant involuntary movements.
Tetrabenazine is a so-called dopamine depletor that works by inhibiting the brain's vesicular monoamine transporter 2.
The Food and Drug Administration has granted the new treatment priority review -- which means Prestwick's drug application will be approved or rejected within six months -- because it treats a serious disease and would represent an advancement over existing therapies.
The FDA has also deemed the drug an orphan drug because the condition it treats affects fewer than 200,000 people, which means the company could get up to seven years' market exclusivity if approved.
Source: United Press International
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