Jazz Pharmaceuticals (NASDAQ:JAZZ) was told by the US Food and Drug Administration that its treatment of fibromyalgia cannot be approved in its current form.
The FDA sent the Palo Alto, California-based company a complete response letter regarding its new drug application for JZP-6 for use in fibromyalgia, a condition characterized by long-term full body pain and tender points in joints and muscles.
In the letter, the federal agency discusses several reasons for its decision, including the need for additional clinical studies, the appropriate patient population, methods for ensuring safe use and the proposed concentration and trade name for the product.
The FDA's decision follows an earlier recommendation against the drug's approval as a treatment for fibromyalgia from an advisory panel that historically carries a lot of weight with the FDA.
Jazz CEO Bruce Cozadd said the drug maker, which specializes on developing treatments for conditions related to neurology and psychiatry, has requested a meeting with the FDA to discuss and clarify the contents of the letter.
From there, it will determine the next step for the drug, which, the company believes, still has the potential to meet a “significant unmet medical need” among fibromyalgia patients.
Currently the drug, JZP-6, or sodium oxybate, is the active ingredient in Xyrem, a treatment of narcolepsy, a condition associated with daytime sleepiness.
The drug, however, carries a risk of addiction and abuse, having been used as a date rape drug, and is therefore classified as a controlled substance, meaning only those meeting strict eligibility requirements are allowed to take it under close monitoring.