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FDA responds to Jazz Xyrem drug application

research-transIn a press release today Jazz Pharma announced that they had received a "FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia."  They said that this was "

regarding the company's New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The CRL states that the FDA cannot approve the NDA in its present form. In the letter, the FDA discusses a number of topics, including the need for additional clinical studies, the appropriate patient population, methods for ensuring safe use, and the proposed REMS, concentration and trade name for the product.

Jazz have requested a meeting with FDA to "

discuss and clarify the contents of the CRL and will then evaluate our next steps for JZP-6 ..... We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA.

says Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.

Full press release from Jazz can be found here.


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