BioCentury
ARTICLE | Company News

Jazz drops fibromyalgia plans

May 4, 2011 12:43 AM UTC

Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ) reported 1Q11 financial results on Tuesday and said it will not conduct the additional trials of sodium oxybate ( JZP-6) that FDA requested in its October 2010 complete response letter for the fibromyalgia candidate. Jazz said the trials would "would take years to complete, would require a significant investment and would not sufficiently reduce regulatory uncertainty." Jazz markets sodium oxybate as Xyrem to treat sleepiness and cataplexy associated with narcolepsy (see BioCentury Extra, Oct. 11, 2010).

Jazz also said it is reevaluating whether or how to proceed with development of intranasal clonazepam ( JZP-8) given the estimated costs, development timeline and competitive environment for the seizure candidate. On a conference call, Jazz said it is looking for new products that are further along in development or already on the market that fit its strategy. ...

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