Wednesday, August 18, 2010

Jazz Pharmaceuticals Fibromyalgia drug Moves One Step Closer to Approval

Well it seems that the FDA panel is fairly positive about the drug, Rekinla according to this article.

Investors are all jazzed up about Jazz Pharmaceuticals (Nasdaq: JAZZ) after the Food and Drug Administration posted on its website fairly positive documents on the company's fibromyalgia drug, JZP-6. A panel of experts will make a recommendation to the agency at Friday's advisory committee meeting. Investors boosted shares as much as 16% before mellowing later in the day.

The drug that treats debilitating pain seems to be on the right path. The documents conclude that the company "provided sufficient evidence to support the efficacy" of the drug. It doesn't get much better than that.

Here is a link to the FDA briefing document on the drug. I think one thing the drug has going for it is that it has already been used for 8 years to treat narcolepsy. The fibromyalgia use of the drug would have the same side effects and Schedule III controlled substance status as that drug. I guess the only bad part is that quite a few more people suffer from fibromyalgia than from narcolepsy so the drug would be more widely available.

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