In case you'd forgotten, the Schedule I substance GHB can be legally prescribed to treat narcolepsy. Unfortunately, Jazz Pharmaceuticals, the company that manufactures GHB and markets it under the brand name Xyrem, is running out of cash, having lost $200 million since its inception - potentially due to the fact that "the narcolepsy market is small, estimated at only 120,000 patients, and sales of Xyrem were just $29 million in 2006."
Its plan now is to start selling shares to the public in hopes of raising a war chest while it tries a new tactic: convincing the FDA to let them market Xyrem to treat fibromyalgia, "a vague and poorly understood pain disorder with symptoms that are often treated with antidepressants."
Jazz is conducting two late-stage clinical trials to prove that Xyrem reduces the pain of fibromyalgia, with results expected in the one trial in the second half of 2008... In an earlier trial, about 30 percent of the people who took Xyrem reported improvement in their fibromyalgia symptoms, compared with 13 percent on a placebo. Whether that figure will be enough to persuade the F.D.A. to approve Xyrem — whose label warns that abuse of GHB can cause “seizure, respiratory depression and profound decreases in level of consciousness” — is not clear.
The company's gotten into trouble, however, as charges have hit ex-employees of promoting off-label use of Xyrem for fibromyalgia; doctors are free to prescribe drugs for anything they want, but companies are prohibited from marketing drugs for unapproved conditions.
Of course, the company does have other offerings besides Xyrem:
With all the clouds over Xyrem, potential investors in Jazz may be pleased to know that it does sell another drug, Antizol, used to treat people who have been poisoned by antifreeze. Unfortunately — or fortunately, perhaps — Antizol’s market is even smaller than Xyrem’s. Antizol had sales of $2.6 million in the first three months of 2007.
GHB is unique among Schedule I substances in that it also sits in Schedule III for the specific case of treating narcolepsy - confusing, given that one of the key premises behind Schedule I substances is that they have no known medical value. If Jazz Pharmaceuticals goes out of business, one wonders who will pick up the torch of trying to manufacture GHB, given the small market and the drug's sketchy history (yes, I have been avoiding devoting another post to George Michael, who turned out to have GHB in his system when cops found him slumped at the wheel of his car). If any of you happen to be nacroleptic, I'd start stockpiling the stuff...
