Jazz Pharmaceuticals Inc released information stating that the US Food and Drug Administration (FDA) has sent the company a complete response letter (CRL) 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 Risk Evaluation Mitigation Strategy, concentration, and trade name for the product.
“We have requested a meeting with FDA in order to discuss and clarify the contents of the CRL and will then evaluate our next steps for JZP-6,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. “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.”