FDA Concurs with Advisory Panel and Rejects Jazz Fibromyalgia Treatment

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The US Food and Drug Administration (FDA) has followed the advice of an Advisory Committee and will not approve Jazz Pharmaceuticals Inc new-drug application for a fibromyalgia treatment called Rekinla (generic name sodium oxybate or JZP-6).

Active Ingredient GHB Has Potential for Abuse, says FDA

Fibromyalgia is a chronic condition characterized by widespread joint and muscle pain, tenderness, fatigue, and decreased physical function. It is believed to affect up to 6 million Americans, mostly women. Currently, only three medications are approved by the FDA for treatment of the poorly understood condition.

The FDA cites safety concerns as the reason for not approving JZP-6. Sodium oxybate is currently approved under the brand name Xyrem as a treatment for narcolepsy, but the dosage for fibromyalgia would differ, according to Jazz Chairman and Chief Executive Bruce Cozadd.

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The drug has the potential for misuse and abuse, says the agency. The active ingredient, gamma hydroxybutyrate or GHB, is used illegally as a “date rape” drug, according to the National Institute on Drug Abuse. Additional clinical trials are necessary to identify the appropriate patient population and methods for ensuring safety.

Cozadd has said that officials with Jazz Pharmaceuticals will meet with FDA representatives "to discuss and clarify the contents of the [complete response letter] and will then evaluate our next steps" for the treatment. "We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6."

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Jazz Pharmaceuticals Inc, based in Palo Alto CA, develops and markets treatments for neurology and psychiatry.

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