Monday, June 15, 2009

Jazz Pharmaceuticals Releases Data on Fibromyalgia Drug

Here is a link to the data on drug and it looks like a winner.

At three months, 54.2% (p<0.001)>

That seems pretty significant and here are the other highlights of what
sodium oxybate also does for the fibromyalgia patient.

-- Patients treated with sodium oxybate 4.5 g/night and 6g/night showed significant reductions in fatigue as early as Week 1 after dosing compared with placebo as measured by the Fatigue VAS (p<0.001). These differences were maintained throughout the 14 weeks of the study (p less than or equal to 0.009).

-- Patients taking sodium oxybate 4.5 g/night and 6g/night showed significant improvement in sleep patterns compared to placebo as measured by the Jenkins Sleep Scale (p<0.001).

-- Statistically significant improvements in mean scores on the Fibromyalgia Impact Questionnaire, a measure of daily function, and on Patient Global Impression of Change were seen in patients receiving sodium oxybate compared to placebo.

-- Sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature. Adverse events were similar to those seen in previous sodium oxybate experience.

-- In this study, the most common adverse events, with incidence greater than or equal to 5% and at least twice the rate of placebo, were headache, nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis.

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