A final FDA decision on Prestwick Pharmaceuticals' Huntington's disease treatment Xenazine (tetrabenazine) is postponed until after the drug is reviewed by FDA's Peripheral and Central Nervous System Advisory Committee, the company announced March 31.

While a date for the Xenazine review has not been finalized, the committee is scheduled to meet May 17.

Prestwick received an FDA "approvable" letter March 24 specifying conditions that the company must meet prior to obtaining approval for the vesicular monoamine transporter 2 inhibitor for the treatment of chorea associated with Huntington's disease; Xenazine is the first product filed in the U.S. for this indication.

The firm plans "to work closely with the FDA to satisfy the conditions specified in the approvable letter and to present the safety and effectiveness of Xenazine to the Advisory Committee," Prestwick CEO Kathleen Clarence-Smith said.

Initially discovered by Roche, tetrabenazine has been marketed for hyperkinetic movement disorders outside the U.S. since the 1980's by various manufacturers.

The committee is already set to convene in May to discuss Novartis' sNDA for Exelon (rivastigmine tartrate) for the treatment of mild-to-moderate dementia associated with Parkinson's disease (¹ Also see "Novartis' Exelon To Be Reviewed By Advisory Cmte. May 17" - Pink Sheet, 27 February, 2006.).

-Mary Bruce

Prestwick's Xenazine Faces Advisory Committee Review

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