FDA to Jazz Pharmaceuticals: Strengthen REMS

FDA sends Jazz Pharmaceuticals a complete response letter for fibromyalgia drug JZP-6.

Jazz Pharmaceuticals received a complete response letter (CRL) from the FDA regarding it’s new drug application for JZP-6 designed to treat fibromyalgia.

JZP-6 is a formulation of sodium oxybate. The CRL indicates that the FDA cannot approve the NDA in its present form. The letter sites the FDA’s request for additional clinical studies, identifying the appropriate patient population, methods for ensuring safe use, and the proposed Risk Evaluation Mitigation Stratehy, 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, in a press release. “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.”

Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes treatments for prominent, underserved markets in neurology and psychiatry.

In August, the company put forth its product, JZP-6, to be evaluated by an FDA joint advisory committee for approval. Among the indications of use, the company provided research and data to suggests that the drug candidate, in addition to treating fibromyalgia, also improves patient sleep quality.

The joint advisory committee included the Arthritis Advisory Committee and the Drug Sagety and Risk Management Advisory Committee. While the committee announced that it agreed the company provided sufficient evidence to support the efficacy of the drug candidate in the treatment of fibromyalgia, the committee ultimately voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of fibromyalgia with the currently proposed REMS.

A press release from the company included a response from Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, Inc: “While we are disappointed with the recommendation of the Joint Advisory Committee, we plan to work closely with FDA on the continuing review of our new drug application (NDA). We will carefully consider the input of the Committee as we seek to address the needs of fibromyalgia patients for new treatment options in a safe and responsible way.”

Jazz Pharmaceuticals original NDA for JZP-6 was accepted in February. The drug was to be reviewed by the FDA within a standard 10-month review periois. The submission included results from two phase III clinical trials, which both demonstrated that the formulation significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality.

According to the American College of Rheumatology (ACR), an estimated 6 million Americans suffer from fibromyalgia.

Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. Sodium oxybate is the active ingredient in XYREM(R) (sodium oxybate) oral solution, approved by the FDA and marketed by Jazz Pharmaceuticals in the U.S. for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy.

Source: Jazz Pharmaceuticals

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