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PALO ALTO, Calif. (
brings its experimental fibromyalgia drug JZP-6 in front of a U.S. Food and Drug Administration advisory committee this morning. This panel of outside experts is being convened to review the clinical efficacy and safety data on JZP-6 and vote on whether to recommend the drug's approval.
Jazz's lead pipeline drug JZP-6 is a close chemical cousin of gamma-hydroxybutyric acid, or GHB, which has been used medically in the past as a general anesthetic but is also abused recreationally as an intoxicant and gained notoriety (not to mention the attention of law enforcement) as a date-rape drug.
The U.S. Drug Enforcement Agency classifies GHB as a Schedule 1 drug, which means it's highly abuse-able, has no medical use and can't be prescribed legally.
Jazz already sells JZP-6 under the brand name Xyrem for the treatment of narcolepsy and to reduce cataplexy (a related condition causing weak or paralyzed muscles.) The FDA approved Xyrem in 2002 with the DEA's assent as a Schedule III, or "limited use" drug. Xyrem is also approved and sold in Europe. Today, the drug does about $100 million annually in sales.
Because Xyrem/JZP-6 (again, think GHB) is a dangerous drug if abused or diverted for non-medical use. The millions of people affected by fibromyalgia (and potential users of Xyrem) dwarfs the relatively small number of narcoleptics (think tens of thousands) who use Xyrem today.
What happens when Xyrem/JZP-6 is made more widely available? Do the risks of JZP-6 abuse and diversion in the general population outweigh the drug's benefits for fibromyalgia patients? I expect those to be the key questions debated and that is the reason why the FDA invited drug safety experts to join the panel's discussion and voting.
-- Reported by Adam Feuerstein in Boston.
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