Jazz Pharma gets US FDA orphan drug designation for JZP-8

The US Food and Drug Administration have granted orphan drug designation to JZP-8, a Jazz Pharmaceuticals, Inc. 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, 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."

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 of approximately 90,000 to 180,000 people.

Orphan drug designation is granted by the FDA to encourage the development of treatments for diseases or conditions that affect fewer than 200,000 patients in the United States. Drug products that receive orphan drug designation obtain seven years of marketing exclusivity from the date of FDA marketing approval, as well as tax credits for clinical trial costs and waivers of marketing application filing fees.

Jazz Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on identifying, developing and commercialising innovative products to meet unmet medical needs in neurology and psychiatry.