FDA Panel Nixes Xyrem for Fibromyalgia, 20 to 2: Here’s what they heard in their deliberations

After various experts made their case on Friday, Aug 20, an FDA advisory committee voted 20 to 2 against issuing a positive recommendation for Jazz Pharmaceuticals’ narcolepsy drug Xyrem (aka “the date rape drug”) as a therapy for fibromyalgia symptoms (for this purpose, dubbed JZP-6). For background, see for example “Treatment of the narcoleptiform sleep disorder in chronic fatigue syndrome and fibromyalgia with sodium oxybate.”

The key sticking point for the panel was fear that broader approval for Xyrem/JZP-6 might “create too many opportunities for abuse & misuse.” A further question being whether it outperforms in some way the three other drugs OK’d for prescription to FM patients.

What the Panel Heard on Behalf of Xyrem/JZP-6 for Fibromyalgia

Reporter Adam Feuerstein reported minute-by-minute on the gist of the presentations in a blog published by TheStreet.com that was joined by more than 400 patients, investors, and clinicians. To read this informative narrative, go to “Jazz Pharma: FDA Panel Live Blog.” Allow time for it all to load, and scroll down at your own speed.

Topics presented by various experts, such as physicians who conducted the various Xyrem studies, and National Fibromyalgia Association President Lynne Matallana, covered:

• History of the drug’s performance in narcolepsy patients.

• Fibromyalgia patients’ need for help with symptoms.

• Design of the Xyrem/FM trials, and efficacy data.

• How the drug helps patients by helping sleep, which in turn may help other symptoms

• FM doctors speak on behalf of the drug, patients’ need for treatment, and drug’s benefit

• Dosing issues (patients take one dose at bedtime & another 3-4 hours later)

• Nature & frequency of adverse events with Xyrem.

• The proposed REMS (risk evaluation and mitigation strategies) plan for Xyrem/JZP-6 if OK’d as a drug for FM.

Commenting on the FDA panel’s decision not to recommend the drug as a Fibromyalgia therapy, Feuerstein said, with the “abuse/misuse issue that loomed large in the room… I think Jazz would have stood little chance of getting Xyrem approved for narcolepsy today.”

The FDA will consider the panel’s recommendation, and issue its final decision on Oct 11.

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