XYREM Update

We’ve noted in previous postings the failure of JAZZ to convince the FDA Advisory Committee that XYREM should be approved for fibromyalgia, and our opinion that the FDA is unlikely to approve the drug as the PDUFA Date approaches.  Motley’s Brian Orelli seems to share our opinion, as do the vast majority of the people responding to his poll.  It does seem meaningful to restate our position at this time, both in support of Mr. Orelli, but also to clarify the regulatory position as we see it.  There were significant issues raised about the RISK associated with this product.  The REMS program offered by XYREM was felt to be inadequate by the Advisory Committee.  More importantly, whatever the drug does or does not do in the intended patient population, in the absence of an adequate REMS program, it increases the risk of the non-patient population with no benefit to these non-patients. The FDA mandate is to protect and promote the health of the US population.  With an inadequate REMS, the FDA must protect and not approve this drug until an adequate REMS is in place.