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FDA Advisory Committee rejects Jazz for fibromyalgia

Jenny Decker RN's picture

Jazz pharmaceuticals Inc faced an FDA Advisory Committee on the hoped approval of its medicine to treat fibromyalgia. The recommendation was not what Jazz had thought it would be. In a vote of 20-2, the FDA Advisory Committee rejected Jazz for treatment of fibromyalgia.

One of the main reasons the drug was rejected was because many on the panel felt that the drug was just too unsafe for approval at this time. The drug contains the chemical GHB, otherwise known as the “date-rape drug’. Although Jazz already has a drug with GHB on the market, Xyrem for narcolepsy, it was felt that the conditions and restrictions placed on the fibromyalgia drug were not enough to prevent an even greater problem with addiction to GHB.

Panel tells Jazz not to give up as many people need pain relief medication

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With the rejection also came some suggestions from the advisory committee. The panel stated that Jazz Pharmaceuticals had not shown them that the drug really was effective for those with fibromyalgia. The work is being done, but has a long way to go. The panel basically told Jazz to not give up because so many people needed the pain relief, but it must be done in a safer way.

Jazz shares dropped after the panel met from $10.23 to $7.35. Jazz had hoped this meeting would raise its shares with an approval. However, Jazz Chief Executive Bruce Cozadd said they would not give up and they would continue to work on the drug with the panels from the FDA to make it better. Cozadd stated to Reuters, “ We will carefully consider the input of the committee as we seek to address the needs of fibromyalgia patients for new treatment options in a safe and responsible way.”

Jazz pharmaceuticals was founded in 2003 and focuses mainly on neurology and psychiatry drugs. Its most current drug on the market is Xyrem. Also on the market is the antidepressant Luvox CR. Other treatments for different disorders are in various stages of research. These include potential treatments for restless leg syndrome, seizures, epilepsy, and bipolar disorder.

There are only 3 other drugs that have been approved for fibromyalgia. These include Pfizer’s Lyrica, Eli Lilly and Co’s Cymbalta, and Forest Laboratories Inc’s Savella. If Jazz is approved, the U.S. brand name of their drug for fibromyalgia is Rekinla.