Jazz Pharmaceuticals, Inc. has announced that the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010. The target date for the FDA to complete its review of the New Drug Application is October 11, 2010.
If approved, sodium oxybate would be the fourth drug to receive approval for the treatment of fibromyalgia. Sodium oxybate is the active...
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FDA Advisory Panel Nixes Sodium Oxybate for Fibromyalgia
By Karen Lee Richards, Health Expert
Last Friday, members of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee overwhelmingly... Read more »
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Xyrem Seeks FDA Approval for Treating Fibromyalgia
By Karen Lee Richards, Health Expert
Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application to the FDA for JZP-6 (sodium oxybate oral solution) for the... Read more »
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FDA Voting on Sodium Oxybate for Fibromyalgia
By Karen Lee Richards, Health Expert
A little over a month ago, I told you that an FDA panel had recommended not approving sodium oxybate for fibromyalgia. On October 11, the... Read more »
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Sodium Oxybate Shows Promise for Treatment of Fibromyalgia
By Karen Lee Richards, Health Expert
Since the FDA approval of Lyrica and Cymbalta for the treatment of fibromyalgia, a number of additional medications are also being tested... Read more »
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RA and Fibromyalgia: An Interview with Karen Lee Richards
By Lene Andersen, Health Expert
Today, May 12, 2011 is National Fibromyalgia Awareness Day. As many of our users live with both RA and fibromyalgia, Karen Lee Richards -... Read more »
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Clinical trial: Xyrem for fibromyalgia
This is a study to evaluate the safety and effectiveness of Xyrem compared to placebo for the treatment of fibromyalgia. This national study is... Read more »
Narcolepsy: Treatment
Source: ADAM Encyclopedia
Lifestyle treatment of narcolepsy includes taking three or more scheduled sleep-times/naps throughout the day. Patients should also avoid heavy meals... Read more »
FDA Panel Rejects New Drug for Fibromyalgia
Experts with the U.S. Food and Drug Administration (FDA) have rejected the drug Xyrem (sodium oxybate) as a treatment for fibromyalgia, saying the... Read more »
Narcolepsy: Highlights
Source: ADAM Encyclopedia
Overview:The word narcolepsy comes from two Greek words roughly translated as "seized by numbness."Narcolepsy affects around 1 in 2,000 people.The... Read more »
Narcolepsy
Source: Harvard Decision Guide
Prevention There is no way to prevent narcolepsy. For people who have the condition, avoiding conditions that bring on narcolepsy episodes may help... Read more »
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