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Jazz drug rejected by FDA advisors

Advisors to the US FDA have voted to recommend against the marketing approval of Jazz Pharmaceuticals' proposed new treatment for fibromyalgia

Advisors to the US Food and Drug Administration (FDA) have voted overwhelmingly to recommend that the federal agency not grant marketing approval to Jazz Pharmaceuticals' proposed new treatment for fibromyalgia.

At the joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panellists voted 20-to-two to recommend that the New Drug Application (NDA) for JZP-6 (sodium oxybate) should be rejected due to concerns about the medicine's potential for abuse and misuse. Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, a potentially dangerous compound that is notoriously abused as a "date rape" drug.

Jazz has proposed a Risk Evaluation and Mitigation Strategy (REMS) that would tightly regulate the drug if it is approved.  The company already markets the narcolepsy drug Xyrem, which also contains sodium oxybate, under a REMS.

However, the panellists worried that because the fibromyalgia market is much larger than the narcolepsy market, the level of abuse of the fibromyalgia drug would also be greater. The narcolepsy drug is distributed through only one US pharmacy, while Jazz has proposed that the fibromyalgia drug would be distributed through 15 pharmacies to meet the larger demand.

A number of the FDA advisors urged Jazz to continue working on ways to ensure that the drug could be sold safely.

Some panellists also said that in order for approval to be feasible, Jazz would need to produce efficacy data showing that the drug was significantly more effective than three less-risky drugs already on the market for fibromyalgia: Pfizer's Lyrica (pregabalin), Eli Lilly's Cymbalta (duloxetine) and Forest Laboratories' Savella (milnacipran).

The FDA frequently follows its panellists' advice, but is not required by law to do so.

"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," said Bruce Cozadd, chairman and CEO of Jazz.

"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."

The NDA for JZP-6 was submitted in February of this year and contained results from two phase III clinical trials showing that sodium oxybate significantly decreased pain and fatigue, boosted daily functioning, and improved sleep quality for fibromyalgia patients. The studies also showed that the drug was well tolerated.

The FDA is aiming to make a decision on the NDA by October 11.

23rd August 2010

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