Jazz Pharma and Alexza/Valeant get FDA complete response letters, delaying JZP-6 and Staccato, respectively

Two bits of negative news came out of the US Food and Drug Administration that will delay the approvals of drug candidates currently under review by the agency, one submitted by Jazz Pharmaceuticals (Nasdaq: JAZZ) and the other by Valeant Pharmaceuticals (NYSE: VRX) partner Alexza Pharmaceuticals (Nasdaq: ALXA).

Jazz saw its share price plunge 10% to $9.06 in pre-market trading yesterday, after it announced that the FDA has sent the company a complete response letter (CRL) regarding its New Drug Application for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The drug - a Schedule III controlled substance and has been linked with “date rape” risk - is currently sold under the brand name Xyrem for the treatment of narcolepsy.

The CRL states that the FDA cannot approve the NDA in its present form. In the letter, the FDA discusses a number of topics, including the need for additional clinical studies, the appropriate patient population, methods for ensuring safe use, and the proposed REMS, concentration and trade name for the product.