FDA posts sodium oxybate briefing documents

FDA said in briefing documents posted ahead a panel meeting on Friday that Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ) provided sufficient evidence to support the efficacy of sodium oxybate for fibromyalgia. The documents also noted that the product, which has a proposed brand name of Rekinla, has a safety profile consistent with that of Jazz's Xyrem, a higher concentration of sodium oxybate marketed for narcolepsy. The agency did express concerns that two different brand names and concentrations of sodium oxybate would cause prescribing errors, including situations where a patient with both fibromyalgia and narcolepsy could inadvertently be prescribed both products and ingest excessive amounts of sodium oxybate. Excessive doses of the compound can cause CNS adverse events that may lead to coma and death as noted in a boxed warning on Xyrem's label.

Jazz proposed a similar but separate REMS for the fibromyalgia product, but FDA said it is unclear whether the separate REMS programs will fully mitigate the risk of misuse and abuse. Additionally, FDA said data do not support the company's proposed labeling claims of improved sleep for fibromyalgia patients. ...