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Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate
Date:1/7/2008

PALO ALTO, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) 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."

About Recurrent Acute Repetitive Seizures

Recurrent acute recurrent repetitive seizures (ARS) are bouts of acute seizure activity occurring within a 24-hour period in adults and a 12-hour period in children. ARS, also called seizure clusters, occurs in a small subset of patients with epilepsy who regularly experience breakthrough seizures in flurries or clusters despite treatment with a regimen of anti-epileptic drugs. ARS is a rare disorder, with an estimated prevalence in the United States
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SOURCE Jazz Pharmaceuticals, Inc.
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