New Fibromyalgia Drug News

FDA panel does not back potential fibromyalgia drug.
Bloomberg News (8/21, Peterson) reported that an FDA panel failed to back a potential "fibromyalgia drug" Rekinla (sodium oxybate), which "includes a chemical linked to date rape," because the drug "doesn't provide enough benefits to outweigh risks of abuse and accidental overdose." The panel voted 20-2 against approval of the drug, which is also currently prescribed under the name brand name Xyrem to treat narcolepsy. Yasmin Choudry, a medical officer in the FDA's division of risk management, said the FDA is concerned "the expanded population and increased availability of the drug in patients' homes may lead to an increase in cases of abuse and misuse, including malicious use."
The Wall Street Journal (8/21, Dooren) notes that many of the FDA panelists also called for long-term data on the safety and effectiveness of sodium oxybate.