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Karen Lee Richards

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Co-Founder of the National Fibromyalgia Assn.
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FDA Advisory Panel Nixes Sodium Oxybate for Fibromyalgia

Last Friday, members of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee overwhelmingly voted (20 to 2) against approving sodium oxybate (brand name Xyrem) for the treatment of fibromyalgia.  While most of the panel members agreed that the drug was effective for some FM patients, their concerns... Read moreChevron
posted 08/25/2010, comments (2)|
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Expert_badge Karen Lee Richards

Karen Lee Richards

(Profile)
Co-Founder of the National Fibromyalgia Assn.
Our Expert |  Living With It
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FDA To Consider Possible New Fibromyalgia Medication

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,... Read moreChevron
posted 06/29/2010, comments (0)|
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Expert_badge Karen Lee Richards

Karen Lee Richards

(Profile)
Co-Founder of the National Fibromyalgia Assn.
Our Expert |  Living With It
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Xyrem Seeks FDA Approval for Treating Fibromyalgia

Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application to the FDA for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.  Sodium oxybate is currently marketed as Xyrem and is thus far only approved for the treatment of excessive daytime sleepiness and cataplexy associated with narcolepsy.  The... Read moreChevron
posted 12/21/2009, comments (0)|
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Expert_badge Karen Lee Richards

Karen Lee Richards

(Profile)
Co-Founder of the National Fibromyalgia Assn.
Our Expert |  Living With It
Get Widget TooltipGet Widget
This widget is a small module that you can place on personalized sites (like iGoogle, Facebook, or your blog) and get automatic updates from our experts!   |  RSS

Sodium Oxybate Shows Promise for Treatment of Fibromyalgia

Since the FDA approval of Lyrica and Cymbalta for the treatment of fibromyalgia, a number of additional medications are also being tested as potential FM treatments.  One of those, sodium oxybate (JZP-6), has shown positive preliminary results in the first of two Phase III clinical trials.  The randomized, double-blind,... Read moreChevron
posted 12/01/2008, comments (3)|
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