Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary...(t sodium oxybate 6 g/night or placebo. T...),Health

Date:6/24/2009

t, sodium oxybate 6 g/night, or placebo. The primary outcome measure, viewed by both U.S. and E.U. regulatory authorities as a clinically meaningful endpoint, was the proportion of patients who achieved at least 30 percent reduction in pain from baseline to endpoint based on the Pain Visual Analog Scale (VAS). Data from the Fibromyalgia Impact Questionnaire (FIQ) are considered equally relevant as Pain VAS data in the E.U. FIQ data are considered supportive data by U.S. regulators.

In the top-line results, significantly more patients treated with sodium oxybate achieved 30 percent or greater improvement in their pain compared to patients treated with placebo. Of those patients receiving sodium oxybate treatment, 35 percent of patients on 4.5 g/night and 35 percent of patients on 6 g/night reported this level of pain relief on the Pain VAS, compared with 20 percent of patients on placebo. These results were highly statistically significant.

Patients' physical functioning and ability to perform daily tasks, as measured by the FIQ, were highly statistically significantly different from placebo for the 4.5 g/night dose and for the 6 g/night dose. Sodium oxybate-treated patients also reported highly statistically significant improvement in fatigue, another common symptom of fibromyalgia.

The most common adverse events (greater than or equal to five percent and at least twice the rate of placebo) were nausea, dizziness, vomiting, insomnia, anxiety, somnolence, fatigue, muscle spasms, and peripheral oedema. Sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature.

"These results from our second Phase III trial, confirming the positive results of our first Phase III study, are an exciting milestone for Jazz Pharmaceuticals," said Bruce Cozadd, Chairman and Chief Executive Officer of Jazz Pharmaceuticals. "I'd like to thank the investigators,
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SOURCE Jazz Pharmaceuticals, Inc.; UCB Copyright©2009 PR Newswire. All rights reserved

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