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Jazz Pharmaceuticals’s fibromyalgia drug candidate will need to undergo more clinical studies, regulators have said. The delay in approving the drug JZP-6 could significantly increase expenses for Jazz, while fresh clinical trials could take a number of years to carry out.
Further information on which patients would benefit from the drug and details on Jazz’s plan for evaluating and reducing the drug’s risks have also been requested by the Food and Drug Administration (FDA). The drug’s chemical name is sodium oxybate.
Jazz said it will discuss the way forward for JZP-6 with the FDA. The firm, which describes the drug as its most advanced candidate, filed for marketing approval in February.
However, the drug was recommended not to be approved by an FDA advisory panel in August, which said the drug’s safety risks did not merit its approval.
Jazz also sells Luvox for social anxiety disorder and Xyrem for daytime sleepiness in patients with narcolepsy and for cataplexy.
Copyright Press Association 2010