FDA panel nixes Jazz drug for fibromyalgia

An FDA advisory panel meeting Friday poured cold water on Jazz Pharmaceuticals' bid to market JZP-6 as a treatment for fibromyalgia as the drug contains a form of gamma hydroxybutyrate (GHB), the so-called "date rape" drug.

Jazz's narcolepsy drug Xyrem contains the same active ingredient as the proposed fibromyalgia treatment. However, panelists--including an FBI agent--figured that it would be too risky to make JZP-6 available to a population of up to 12 million people in the U.S. The potential for abuse would just be too great, they said.

The panelists did agree that the drug--which Jazz wants to market under the brand name Rekinla for fibromyalgia--did show potential as a treatment for that disorder. But as Forbes reports, Jazz's plans for managing the risks of the drug weren't robust enough to ease the committee's fears. "The risk is huge," Baylor College of Medicine's Dr. Thomas Kosten said during the meeting (as quoted by Reuters). "The complications of this drug are not small."

The company says it will continue working with FDA on its application. "We will carefully consider the input of the committee as we seek to address the needs of fibromyalgia patients for new treatment options in a safe and responsible way," CEO Bruce Cozadd says in a statement.

- get the Jazz release
- read the Forbes story
- get more from Reuters
- see the Wall Street Journal Health Blog post

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