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VIDEOJazzing Up a Date Rape Drug
Jazz Pharmaceuticals faces an FDA Advisory Committee that's scrutinizing its potential fibromyalgia treatment.
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The Arthritis Drugs Advisory Committee and the Risk Management Advisory Committee are reviewing Jazz Pharmaceuticals's (JAZZ) lead drug compound JZP-6, proposed brand name Rekinla, for the treatment of fibromyalgia, a disease that affects an estimated 5.8 million Americans and is known to cause long-term, body-wide pain. Analysts estimate the drug, if approved, could bring in revenues of $300 million or more.
JZP-6 has already been approved by the FDA in 2002 under the name Xyrem for the treatment of narcolepsy, a sleep disorder that affects one in every 2,000 Americans. So why should the FDA be nervous about approving Xyrem for wider use?
Well, Xyrem is also known by the chemical name gamma-hydroxybutyrate -- but you may recognize it as the date-rape drug GHB. The drug became popular during the 1980s and 1990s on the club scene due to its euphoric effects and its ability to induce sleep and even memory loss -- it was also easily masked by alcohol because it can be an odorless, colorless liquid. The FDA qualified the drug as a Schedule I substance in 2000, making it off-limits for selling or medicinal use.
The oversight agency backtracked a little with the approval of Xyrem, but only because the population that uses Xyrem is a rather small one and Jazz provided the agency with a thorough risk-management plan.
During the Advisory Committee meeting, panelists noted that the incidence of GHB abuse has actually gone down since Xyrem hit the market -- a good sign for the potential approval of the drug for wider use.
Yet, wider use could be just the problem. With more than 5.8 million fibromyalgia patients in the US, a significant number of people would now have access to the potential date-rape drug.
Fibromyalgia is also a disease that's easily faked because the diagnosis relies heavily on the patient’s own reporting of aches and pains -- not quantifiable tests. The disease caused a host of controversy when Pfizer (PFE) began marketing Lyrica for treatment because many critics believe it's not a disease at all. Critics have gone as far as to call the disease something that's been made up by the pharmaceutical industry to drive revenues (but the legitimacy of fibromyalgia isn't an issue the FDA will be discussing).
It also doesn’t help Jazz’s cause that there are plenty of fibromyalgia treatments already out there -- treatments that may have some nasty side effects, but don't have the abuse potential of Xyrem.
The panel will vote on the approvability this afternoon, but ultimately, the FDA will decide by October 11 whether or not the general public should have broader access to this potentially dangerous drug.
For now, Jazz is staying positive; its chairman recently made comments on a conference call that cited the eight years of experience the company has had mitigating abuse risks for the drug.
Twitter: @biowriterchik
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