Navigation Links
Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia
Date:10/11/2010

PALO ALTO, Calif., Oct. 11 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) 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."

Conference Call Information

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today (October 11) at 8:30 AM Eastern Time/ 5:30 AM Pacific Time to discuss this release and respond to investor questions.  The live webcast may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary.

Investors may participate in the conference call by dialing 866-700-6067 in the U.S., or 617-213-8834 outside the U.S., and entering passcode 43104766.

An archived version of the webcast will be available for at least one week on the investors section of the Jazz Pharmaceuticals' website at www.jazzpharmaceuticals.com.

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals (Nasdaq: JAZZ) 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.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

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.


'/>"/>
SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Announces Initiation of XIAFLEX® Phase III Studies for Peyronies Disease
2. Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aerosol NDA
3. Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA
4. Bexion Pharmaceuticals Continues to Gain Support from National Cancer Institute (NCI)
5. Onyx Pharmaceuticals Provides Status Update on Carfilzomib
6. Onyx Pharmaceuticals Announces Teleconference to Provide Status Update on Carfilzomib
7. Star Scientific Comments on Roskamp Institutes Plans to Conduct Human Alzheimers Clinical Trials Using a Compound (RCP-006) Developed by Rock Creek Pharmaceuticals, Inc.
8. VentiRx Pharmaceuticals Reports Positive Clinical Data for VTX-1463 in Allergic Rhinitis
9. Regeneron Pharmaceuticals, Inc. Announces The Sale of 4,500,000 Shares of Common Stock
10. Lotus Pharmaceuticals Retains Sichenzia Ross Friedman Ference LLP as General Legal Counsel
11. ISTA Pharmaceuticals Reports Positive Preliminary Results from its Phase 1/2 Clinical Study of Bepotastine Besilate Nasal Spray for the Treatment of Symptoms Associated with Seasonal Allergic Rhinitis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... The global immunomodulators market is expected ... to a new study by Grand View Research, ... driven by high R&D investments employed by the ... new and therapeutically advanced drugs. This is believed ... unprecedented rate into the immunomodulators market hence providing ...
(Date:1/19/2017)... , Jan. 19, 2017 Report Details ... ... Opportunities for Leading Companies – our new study reveals ... discusses issues and events affecting the Alzheimer,s disease therapeutics ... to answer these key questions: - How is the ...
(Date:1/19/2017)... 2017 According to a study conducted by ... to witness a CAGR of 6.5% during the forecast period 2016-2024. ... continue to be the leading market for cryotherapy globally during the ... Highlights ... ensuring affordable and adequate supply of gas in order to provide ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... January 20, 2017 , ... “The Angel”: a heartwarming ... set out for each of his children. “The Angel” is the creation of published ... in New York City, and impassioned writer. , When asked of her new book, ...
(Date:1/20/2017)... ... ... Forgive You”: a fine examination of how God handles sin, including how to let ... Stephen Miller, who, for over ten long years has been waiting to release this powerful ... Tobago, he has been serving the Lord for over twenty years, and he has been ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... “Christmas in ... creation of published author, Sara Seymour, who lives in Lafayette, Indiana where she works ... sips on iced coffees and writes. , Published by Christian Faith Publishing, Sara Seymour’s ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... “Knowledge is ... be guided by faith. “Knowledge is God’s Lighthouse” is the creation of published author, ... cookbooks, novels, and poetry collections. , “I have been writing since high school ...
(Date:1/20/2017)... ... January 20, 2017 , ... “God's Miracle Man: Against All Odds”: ... creation of published author, Keith C. A. Tucker, son of Minister Delores Pinnock and ... pastured by Reverend Mark Hardy , “While sitting up in bed, I felt a ...
Breaking Medicine News(10 mins):