Xyrem Advisory Committee Meeting – the post mortem

The FDA Advisory Committee meeting is now in the history books and the hopes of JAZZ Pharmaceuticals for Xyrem having a fibromyalgia indication seem lost forever.  We monitored the discussion throughout the day and were happy to see that the Panel members weren’t pulling any punches.  They confirmed our August 19, 2010 opinion that the risk clearly outweighed the benefits.  The only surprise of the day came when the FDA ended the voting after the Panel declared that the proposed REMS program from JAZZ was inadequate.  This avoided an up and down vote on the safety of the drug.  We imagine that the Panel would have voted overwhelmingly negative on the safety of the drug.  Accompanying that vote would have been an equally negative dialog that would have challenged the wisdom of keeping the drug on the market.  In the absence of that negative vote, FDA and JAZZ can strengthen the existing REMS program and be in a stronger position to respond to the calls to withdraw the drug which are likely to be made.