An FDA advisory panel today rejected sodium oxybate (Xyrem), the application of Jazz Pharmaceuticals, as a treatment for fibromyalgia. Xyrem is chemically similar to GHB, which is infamous as a date-rape drug. "Sodium oxybate and GHB are the same thing," said panelist Lewis Nelson, MD, of the New York University School of Medicine. "This is much better than the stuff you get on the street, and that is the problem."
Currently, the drug, which was introduced in 2002, is used for the treatment of narcolepsy. "When drugs like GHB get out there, we wish it hadn't happened," said Thomas Kosten, MD, a Baylor University professor of psychiatry and addiction.
"Without any data to show that this is better than existing medications, I think we are foolish to consider approving this drug," Kosten added.
Earlier Jazz had provided data included two studies measuring pain relief, and one study tested the effectiveness of drug as a sleep aid. "The agency agrees that there is evidence of efficacy for treating pain,” said FDA statistician David Petullo, MS, who reviewed the studies. The FDA rejected Jazz's claims that sodium oxybate had a positive effect on sleep.
Talking to WebMD, Jon Russell, MD, director of the University Clinical Research Center at the University of Texas Health Science Center at San Antonio said, "We need more options for the care of fibromyalgia patients and those should have different mechanisms of action." Russell spoke on behalf of Jazz. The panelists said that Jazz failed to make enough of an effort to prove the effectiveness of sodium oxybate.
