Jazz Pharmaceuticals, Inc. (In a press release) announced today that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its JZP-8 product candidate for the treatment of recurrent acute repetitive seizures. In December 2007, Jazz Pharmaceuticals dosed the first patient in a Phase II clinical trial of JZP-8.JZP-8 is a novel drug delivery formulation incorporating clonazepam, a widely prescribed benzodiazepine. The product candidate is designed to be a fast-acting intranasal spray for the treatment of recurrent acute repetitive seizures in patients with epilepsy. Jazz Pharmaceuticals previously completed development activities to select the active pharmaceutical ingredient for the product, to determine its formulation, and to assess its safety and tolerability in early stage studies."JZP-8 is one of the first development product candidates from our internal product identification and development program to enter Phase II," said Samuel R. Saks, M.D., Chief Executive Officer of Jazz Pharmaceuticals. "Dosing of the first patient in our Phase II clinical trial and receipt of orphan drug designation are important milestones for this program."
Tuesday, 8 January 2008
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