Prestwick's Xenazine receives FDA approvable letter

USA-based drugmaker Prestwick Pharmaceuticals says it has received an "approvable" letter from the Food and Drug Administration relating to its developmental reversible dopamine depleting agent Xenazine (tetrabenazine) and its use in the treatment of chorea associated with Huntington's disease. The document sets out the criteria the drug must meet before it is licensed for sale on the US market and announces the FDA's intention to discuss the company's New Drug Application at a public meeting of its Central Nervous System Advisory Committee.

Chorea is a disease of excessive, involuntary movements caused in HD by the overactivity of the neurotransmitter dopamine. The condition effects 30,000 patient in the USA and has no recognized treatment approach. As a result, the FDA has designated the compound an Orphan Drug and ear marked it for fast-track consideration. Currently, the product is approved in eight markets outside the USA and is commercialized by the firm as Nitoman in Canada.