Recently I told you that an FDA panel had recommended not approving sodium oxybate for fibromyalgia. On Monday, the FDA agreed with the panel's decision. They sent Jazz Pharmaceuticals, Inc., the manufacturer of sodium oxybate, 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 REMS, 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 chief executive officer 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."
I'm disappointed with the FDA's decision. New clinical trials could take years, which would significantly increase the cost to Jazz Pharmaceuticals and ultimately to the patients. It's not as if the studies already done didn't prove sodium oxybate's effectiveness for fibromyalgia. Apparently, the FDA now wants proof that it works better than the other medications already approved to treat FM, or that it works for FM patients who were not helped by the other drugs.
As for the proposed REMS, I can't imagine how they could be strengthened much more. The current REMS for sodium oxybate are among the most stringent I've seen. As I said before, I don't know what else they could do short of sending someone to your home to watch you take the medication.
At this point, we can only hope that the FDA will be reasonable when they meet with Jazz Pharmaceuticals and their requests won't be so difficult and expensive that Jazz will be forced to give up seeking approval for sodium oxybate.
Source: Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia. PR Newswire. October 11, 2010.
Published On: October 13, 2010