Biotech Values

[Biowatch]

JAZZ -- safe for fibromyalgia, but risky.

The Food and Drug Administration posted its review online, saying Jazz's drug sodium oxybate effectively treated pain from fibromyalgia in two company-run studies. However, regulators have concerns about the misuse and abuse of the drug, which has been used as an illegal stimulant and a date rape drug.

Fibromyalgia is characterized by widespread muscle pain and other symptoms including fatigue, headache and depression.

...Between 2002 and 2009, the FDA identified just five cases of misuse or abuse of the drug.

http://finance.yahoo.com/news/FDA-eyes-Jazz-Pharmaceuticals-apf-1748734768.html?x=0&.v=3

This has to be a tough call for the FDA. It's approved for 150,000 narcolepsy patients, but opening up the market for several million fibromyalgia patients increases the potential for abuse.

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm217265.htm

Agenda

The committees will discuss new drug application (NDA) 22-531, sodium oxybate, 375 milligrams per milliliter (mg/ml) oral solution, sponsored by Jazz Pharmaceuticals, with a proposed indication for the treatment of fibromyalgia for patients 18 years of age and older. The safety and efficacy findings for sodium oxybate in the fibromyalgia population and the proposed Risk Evaluation and Mitigation Strategy (REMS) for this product will be discussed.