Enrollment complete in Ph III trial of Jazz' fibromyalgia drug
The USA's Jazz Pharmaceuticals has completed enrollment in the second of two Phase III pivotal trials of JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The firm expects to report top-line results in mid-2009.
The JZP-6 Phase III trial program includes two randomized, double blind, placebo-controlled studies. The first was completed and positive top-line results were announced in November 2008. The second has enrolled 575 patients at centers in the USA and Europe.
Jazz anticipates submitting a New Drug Application for sodium oxybate to the US Food and Drug Administration by the end of 2009. Belgian drugmaker UCB has the exclusive marketing and distribution rights to the compound for fibromyalgia in Europe and many other countries outside North America.
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