Currently, over 20 drugs are in development for the treatment of fibromyalgia. That number is expected to grow in the next year.
At present, the only drug to be approved for the treatment of fibromyalgia, by the FDA, is Lyrica. Sales of Lyrica are expected to reach $641 million in 2016 according the business forecasting company Datamonitor. Overall, Datamonitor expects the fibromyalgia drug market to reach the $2 billion mark by the year 2016. In 2006 the total reported fibromyalgia drug sales were $400 million (which was mainly off-label prescriptions).
Recently, Eli Lilly has submitted Cymbalta to the FDA for approval in the treatment of fibromyalgia. They expect Cymbalta to be approved in 2008 by the FDA, for the treatment of fibromyalgia, once clinical trials are complete.
Cymbalta is currently approved by the FDA for the treatment of depression and diabetic peripheral neuropathy (DPN). In the treatment of depression it takes approximately 1-4 weeks for Cymbalta to become effective. If the same time frame is needed for the control of fibromyalgia pain is not clear. Sexual dysfunction is one of the suspected side-effects.
Cymbalta’s manufacturer, Eli Lilly, expanded the drug’s warning label in respect to possible liver-related problems and to warn physicians against prescribing it to patients with chronic liver disease. The new label also includes warnings of hepatitis, jaundice and other liver-related problems.