More data needed for experimental Fibromyalgia drug

The FDA has told Jazz Pharmaceuticals Inc. (JAZZ) it can’t approve the company’s new-drug application for a fibromyalgia treatment JZP-6 in its present form. The Palo Alto, CA-based company’s shares price dropped 10% to $9.06 in light pre-market trading, after the company announced the FDA ruling.

The agency issued one of its complete response letters for the drug requiring more clinical data. Jazz said in a release “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.”

The company is evaluating the agency’s requests as it ponders how it should proceed, according to Jazz.

The agency’s rejection to this drug was not a big surprise, as in August this year, an expert panel voted overwhelmingly against approval saying the agent doesn’t provide sufficient benefits to outweigh risks of abuse and accidental overdose. While the regulator held back an endorsement for the drug, 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.

The drug is currently sold under the brand name Xyrem for narcolepsy, a condition marked by excessive daytime sleepiness.

Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function. It is believed to affect up to 6 million Americans, mostly women, and is marked by widespread muscle pain, tenderness and fatigue. The condition traditionally has been treated with a mix of painkillers and antidepressants. There are only 3 other drugs that have been approved for fibromyalgia. These include Pfizer’s Lyrica, Eli Lilly and Co’s Cymbalta, and Forest Laboratories Inc’s Savella.