Navigation Links
Jazz Pharmaceuticals' JZP-6 to be Reviewed at a Joint Meeting of the FDA's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee on August 20, 2010

PALO ALTO, Calif., June 24 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010.

In February 2010, the FDA accepted for filing and review the New Drug Application (NDA) of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.   The target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.  

About Sodium Oxybate

Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. Sodium oxybate is the active ingredient in XYREM® (sodium oxybate) oral solution, approved by the FDA and marketed by Jazz Pharmaceuticals in the U.S. for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The most commonly reported adverse drug reactions in narcolepsy patients are dizziness, nausea and headaches. Sodium oxybate has the potential to induce respiratory depression and neuropsychiatric events. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.

About Fibromyalgia

Fibromyalgia is a chronic condition characterized by widespread pain. Fibromyalgia is believed to be a central nervous system condition, resulting from neurological changes in how the brain perceives and responds to pain. In addition to pain, the main symptoms are fatigue, disturbed sleep and morning stiffness.  The exact causes of fibromyalgia are unknown. It may be triggered by physical trauma, emotional stress, chronic pain or infection. Genetics, neurochemicals that affect pain modulation, neurohormones and sleep physiology abnormalities are thought to play a role. Research also has suggested a relationship between sleep and pain. Fibromyalgia patients experience a high prevalence of sleep problems, including a reduction in non-restorative or deep sleep.

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

SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. ( Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
(Date:11/25/2015)... WILMINGTON, N.C. , Nov. 25, 2015 /PRNewswire/ ... announces the planned investment of at least $15.8 ... in Wilmington, NC . The ... services capacity to meet the growing demands of ... Wilmington site expansion will provide up ...
(Date:11/25/2015)... N.Y. , Nov. 25, 2015  Henry Schein, ... and services to office-based dental, medical and animal health ... (GNYDM) Meeting the Henry Schein ConnectDental® Pavilion , ... broadest array of open solutions designed to help any ... Click here for a schedule of experts ...
(Date:11/25/2015)... , Nov. 25, 2015  Trovagene, Inc. (NASDAQ: ... announced that Chief Executive Officer Antonius Schuh, Ph.D., is ... th Annual Piper Jaffray Healthcare Conference. ... New York Palace Hotel in New York ... p.m. EST. Mr. Schuh will be available for one-on-one ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... According to an article published ... Toronto and the University of British Columbia suggested that laws requiring bicyclists to wear ... explains that part of the reason for the controversial conclusion is that, while helmets ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... A team ... ways to treat it. Surviving Mesothelioma has just posted the findings on the ... University Hospital Zurich analyzed the cases of 136 mesothelioma patients who were treated with ...
(Date:11/27/2015)... ... November 27, 2015 , ... Lizzie’s Lice Pickers just announced a special promotion ... off of their purchase of lice treatment product. In addition, customers will receive a ... company spokesperson. “Finding lice is a sure way to ruin the holidays, so we ...
(Date:11/27/2015)... ANGELES, CA (PRWEB) , ... November 27, 2015 , ... MPWH, the No.1 Herpes-only dating ... of 30 (see Table 1-1 ). More than 3.7 billion people under the ... virus type 1 (HSV-1), according to WHO's first global estimates of HSV-1 infection . ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television series, "Voices in America", ... delves into an array of issues that are presently affecting Americans. Dedicated to providing ... this show is changing the subjects consumers focus on, one episode at a time. ...
Breaking Medicine News(10 mins):