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news.Jazz Pharmaceuticals has received orphan drug designation from the FDA for its JZP-8 product candidate for the treatment of recurrent acute repetitive seizures.
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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.
In December 2007, Jazz Pharmaceuticals dosed the first patient in a Phase II clinical trial of JZP-8.
Samuel Saks, CEO of Jazz Pharmaceuticals, said: “Dosing of the first patient in our Phase II clinical trial and receipt of orphan drug designation are important milestones for this program.”