Jazz Pharmaceuticals and UCB Announce Positive Phase III Results for Sodium Oxybate (JZP-6) in Fi...(tors. In the top-line results a...),Health

In the top-line results, a significant number of 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, 46.2 percent of patients on 4.5 g/night and 39.3 percent of patients on 6 g/night reported this level of pain relief, compared with 27.3 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 significantly different from placebo for the 4.5 g/night dose and approached significance for the 6 g/night dose.

Patients receiving sodium oxybate also reported significant improvement in fatigue, another common symptom of fibromyalgia, at both active dosage levels.

Adverse events were similar to those seen in previous experience with sodium oxybate. The most common adverse events, with incidence greater than or equal to 5 percent and at least twice the rate of placebo, were headache, nausea, dizziness, vomiting, diarrhea, anxiety, and sinusitis. Sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature.

"Achieving positive sodium oxybate (JZP-6) data in fibromyalgia from this Phase III clinical trial is an exciting milestone for Jazz Pharmaceuticals, and supports our commitment to developing products that can improve outcomes for patients with serious medical conditions," said Samuel Saks, M.D., Chief Executive Officer of Jazz Pharmaceuticals.

"As UCB continues to focus on serious diseases of the central nervous system and immunology, we are delighted to partner with Jazz Pharmaceuticals in bringing new hope for patients with this under-treated condition," said Roch Doliveux, Chief Executive Officer of UCB.

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