The FDA has handed Jazz Pharmaceuticals a setback, spurning its application for a new therapy to treat fibromyalgia and sending the developer back to the drawing board for fresh data on JZP-6 that could take years to gather.
The agency issued one of its complete response letters for the drug. "In the letter," Jazz notes in a release, "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." Palo Alto, CA-based Jazz says it is evaluating the agency's requests as it ponders how it should proceed.
The agency's response wasn't a big surprise. Back in August, an expert panel voted overwhelmingly against approval, worried that a drug relying on a form of the "date-rape" drug gamma hydroxybutyrate, or GHB, was ripe for abuse.
But while the experts and the FDA held back an endorsement, there's also broad consensus that further study and a better risk-control program could make this a valuable addition to the therapies being used to treat the pain disorder. Shares of Jazz slid 11 percent this morning in pre-market trading.
- here's the Jazz release
- read the Dow Jones report