Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia
-- Company to host conference call on Monday, October 11 at 8:30 AM ET --
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An archived version of the webcast will be available for at least one week on the investors section of the Jazz Pharmaceuticals' website at www.jazzpharmaceuticals.com.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.