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Jazz fibromyalgia drug not approvable

The US Food and Drug Administration has notified Jazz Pharmaceuticals that fibromyalgia treatment JZP-6 is not approvable in its current form

Jazz Pharmaceuticals has been notified by the US Food and Drug Administration (FDA) that the New Drug Application (NDA) for its experimental fibromyalgia treatment currently called JZP-6 (sodium oxybate) is not approvable in its current form and that additional clinical studies will be required.

The product is a version of the company's approved sodium oxybate drug Xyrem, which is marketed in the US for the treatment of cataplexy and excessive daytime sleepiness associated with narcolepsy.

An advisory committee for the FDA had previously voted to recommend against marketing approval for the drug.

In a Complete Response Letter (CRL) to the company regarding the fibromyalgia product, the FDA indicated that it would require additional clinical studies, clarification regarding the appropriate patient population, revisions to the proposed Risk Evaluation and Mitigation Strategy (REMS) for the product, and resolution of issues concerning the proposed tradename and the concentration of the drug, which differs from Xyrem's concentration.

The company said it has requested a meeting with the FDA to discuss the issues.

In a conference call with investors, Jazz chairman and CEO Bruce Cozadd said that the additional clinical studies being requested by the FDA would need to be designed to evaluate safety in patients taking concomitant medications and to generate additional information related to selection of appropriate patients.

Cozadd said the FDA's letter also raises concerns about the risk of accidental overdose, particularly given the dosing schedule, which involves taking one dose in the middle of the night. 

"We are both surprised and disappointed with the CRL," Cozadd said during the call, noting that the company had believed that the outstanding issues were only the concentration and tradename, and had taken steps to address them. "Following an August 20 advisory committee meeting, we submitted additional information and revisions to the REMS to address these points. However, the FDA stated in the CRL that it did not factor that information into its comments in the letter."

Cozadd indicated that the company is not yet clear on the eventual fate of the product. "Until we obtain additional clarification from the FDA, it's difficult to speculate about the scope, timing and cost of any additional activities required to support the fibromylagia NDA," he said. Asked whether the company would complete development of the fibromyalgia drug, he replied that it is "just too early to say."

12th October 2010

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