Jazz seizure drug receives FDA orphan status

PALO ALTO, Calif. The Food and Drug Administration has granted orphan drug status to Jazz Pharmaceuticals’ new drug candidate, JZP-8, which is used to treat recurrent acute repetitive seizures. The drug is designed to be a fast-acting intranasal spray for the treatment of recurrent acute repetitive seizures in patients with epilepsy.

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 U.S. of approximately 90,000 to 180,000 people.

In December 2007, Jazz Pharmaceuticals dosed the first patient in a Phase II clinical trial of JZP-8. “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, chief executive officer of Jazz Pharmaceuticals.