We just published a report on sodium oxybate – better known as GHB, a powerful nervous system depressant that gained notoriety in the 1990s as a  “date rape” drug. Despite its reputation and schedule I restriction, FDA approved a branded GHB formulation, Xyrem, for treating narcolepsy. In 2009, Xyrem sales accounted for about $97 million in revenue for Jazz Pharmaceuticals, which is now seeking to expand the market opportunity for Xyrem into fibromyalgia, a much more prevalent condition.

Jazz reported positive phase III studies last year and submitted its marketing application to FDA, putting it on track for a regulatory decision in mid-October. An approval would be a boon to Jazz. But will FDA view significant efficacy as sufficient to justify approval in a much broader population with a non-life-threatening condition, given the complex history and track record of GHB in other settings? In this report we weigh these and other issues as we attempt to gauge the likelihood of regulatory success for Xyrem this Fall in fibromyalgia