ARTICLE | Clinical News

Sodium oxybate regulatory update

August 23, 2010 7:00 AM UTC

A joint meeting of the Arthritis Drugs and the Drug Safety and Risk Management committees voted 20-2 that the benefit/risk profile of sodium oxybate did not support approval to treat fibromyalgia. While most panel members felt that Jazz demonstrated efficacy, they were concerned about the interaction of the treatment with concomitant medications like opioids and benzodiazepines frequently taken by patients with fibromyalgia. They also were concerned with the potential for abuse and misuse of the drug if it is approved for fibromyalgia, which is a much larger patient population than the narcolepsy population for which sodium oxybate is already approved.

The panel agreed that a stronger REMS than the one proposed by Jazz was necessary to reduce the likelihood of misuse and abuse in fibromyalgia. The committee also recommended additional studies in fibromyalgia patients taking concomitant medications. Such medications were not allowed in the Phase III program. ...