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news.The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Jazz Pharmaceuticals regarding its new drug application (NDA) of JZP-6 (sodium oxybate) for the treatment of fibromyalgia, stating that it cannot approve the NDA in its present form.
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In the letter, the FDA discussed 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 Pharmaceuticals chairman and CEO Bruce Cozadd said that they have requested a meeting with FDA in order to discuss and clarify the contents of the CRL and will then evaluate the 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," Cozadd said.
Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercialises treatments for important, underserved markets in neurology and psychiatry.