JZP-6Treatment for Fibromyalgia
Complete Response Letter for JZP-6 NDA
Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia
PALO ALTO, Calif., Oct. 11 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has sent the company a complete response letter (CRL) regarding the company's New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The CRL states that the FDA cannot approve the NDA in its present form. In the letter, the FDA discusses a number of topics, including the need for additional clinical studies, the appropriate patient population, methods for ensuring safe use, and the proposed REMS, concentration and trade name for the product.
"We have requested a meeting with FDA in order to discuss and clarify the contents of the CRL and will then evaluate our next steps for JZP-6," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA."
Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. For further information see www.jazzpharmaceuticals.com.
This press release contains forward-looking statements, including but not limited to statements related to Jazz Pharmaceuticals' JZP-6 (sodium oxybate) product candidate, including statements related to Jazz Pharmaceuticals' plans to meet with the FDA, the outcome of any such meeting and all future regulatory matters, including its future approval and the future development of JZP-6. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the uncertain and time-consuming regulatory approval process for JZP6, risks related to potential further development of JZP-6, and other risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on August, 11, 2010. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
CONTACT: Ami Knoefler, Executive Director, Investor Relations & CorporateCommunications of Jazz Pharmaceuticals, Inc., +1-650-496-2947, email@example.com
Web site: http://www.jazzpharmaceuticals.com/
Ticker Symbol: (NASDAQ-NMS:JAZZ)
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Posted: October 2010
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