Navigation Links
Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia
Date:2/18/2010

o moderate in nature and similar to those seen in previous trials with narcolepsy.  Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.

Fibromyalgia is a complex musculoskeletal disorder clinically characterized by widespread pain usually accompanied by fatigue, insomnia, and dyscognition.  According to the American College of Rheumatology (ACR), an estimated 6 million Americans suffer from fibromyalgia.  

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
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Transdel Pharmaceuticals Announces Management Reorganization
2. Merz Pharmaceuticals Introduces New Mederma(R) Stretch Marks Therapy Now Available in Drugstores Nationwide
3. GlaxoSmithKline President of North America Pharmaceuticals, Deirdre Connelly, Named 2010 Woman of the Year by the Healthcare Businesswomens Association
4. Oramed Pharmaceuticals Expands Scientific Advisory Board With the Appointment of John Amatruda, M.D.
5. Alexza Pharmaceuticals to Host 2010 Investor/Analyst Day on Thursday, February 18, 2010
6. Endo Pharmaceuticals to Announce Fourth Quarter and Full Year 2009 Financial Results on February 22, 2010
7. Amira Pharmaceuticals Announces Efficacy of LPA1 Antagonist in a Preclinical Model of Scleroderma
8. ISTA Pharmaceuticals Announces 2010 Financial Guidance
9. Savient Pharmaceuticals To Hold Fourth Quarter And Year-End 2009 Results Conference Call On Friday, February 26, 2010
10. Sagent Pharmaceuticals Announces FDA Approval of Labetalol Hydrochloride Injection, USP
11. Anthera Pharmaceuticals Announces Agreement With the FDA on a SPA for Planned Phase 3 Varespladib A-002 Study; Daniel K. Spiegelman Joins Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/23/2014)... HARRISBURG, Pa. , Sept. 23, 2014 ... prescription drugs Sat., Sept. 27, as part of National ... anonymous, no questions asked. Take-Back Day is ... Drug Enforcement Administration (DEA), aimed at encouraging the public ... that are prone to abuse and theft. ...
(Date:9/23/2014)... 2014 Galmed Pharmaceuticals Ltd. (Nasdaq: ... focused on the development and commercialization of a ... diseases and cholesterol gallstones, announced today that the ... approved its request for Fast Track Designation of ... Non-Alcoholic Steato-Hepatitis, or NASH.  FDA ...
(Date:9/23/2014)... , Sept 23, 2014  Vesselon, Inc. today announced ... of Directors, effective September 15, 2014. Dr. Raths, appointment ... its placement agent to market a private preferred Series ... early stroke treatment. "Jurgen,s deep experience across ... a great asset to Vesselon as we develop our ...
Breaking Medicine Technology:Galmed Pharmaceuticals Announces U.S. FDA Approval of Fast Track Designation of Aramchol for the Treatment of NASH 2Galmed Pharmaceuticals Announces U.S. FDA Approval of Fast Track Designation of Aramchol for the Treatment of NASH 3Vesselon Announces Jurgen Raths, MD to Serve on Board of Directors 2Vesselon Announces Jurgen Raths, MD to Serve on Board of Directors 3
... Novavax, Inc. (Nasdaq:,NVAX) today announced that it ... vaccine candidate against Severe Acute Respiratory Syndrome,(SARS). The ... Institutes of Health (NIH) to continue preclinical development ... "Until now, it has been difficult to ...
... Three of Four HUMIRA Patients from CHARM Study in Remission ... ... May 21 Results from an,open-label extension study of two ... patients treated with,HUMIRA(R) (adalimumab) achieved long-term clinical remission and clinical,response, ...
Cached Medicine Technology:Novavax Announces Proprietary Method to Create SARS Vaccine and Renewal of NIH Funding for SARS Vaccine Development 2Novavax Announces Proprietary Method to Create SARS Vaccine and Renewal of NIH Funding for SARS Vaccine Development 3Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission 2Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission 3Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission 4Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission 5Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission 6Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission 7
(Date:9/23/2014)... CA (PRWEB) September 23, 2014 Oaksterdam ... Industry Today . In its first post, the University ... growing and changing cannabis industry. , The cannabis industry ... Colorado alone is expecting an 18-month boost of more ... and adult use pot sales. And, the new legal ...
(Date:9/23/2014)... throughout the first year follow a set of ... syllables and first words. However, previous research had ... differ between hearing and deaf infants. Now, University ... primarily motivated by infants, ability to hear their ... who received cochlear implants to help correct their ...
(Date:9/23/2014)... FL (PRWEB) September 23, 2014 ... of the newly renovated Women’s Health Center on ... feet of space, the specially designed center offers ... in East Pasco County. The Women’s Health Center ... pelvic floor health, labor and delivery through The ...
(Date:9/23/2014)... "The primary purpose of the CALL LIGHT CADDY is ... Ca.. "Call lights are often found on the floor, lost ... pole out of the patient's reach. In order to make ... need it, I created this caddy." , She developed the ... within easy reach. The accessory ensures that the call device ...
(Date:9/23/2014)... studies found that FDG-PET technology is less accurate ... regions where infections like histoplasmosis or tuberculosis are ... cancer could lead to unnecessary tests and surgeries ... , Histoplasmosis and other fungal diseases are ... bird droppings and are found in soils. , ...
Breaking Medicine News(10 mins):Health News:Oaksterdam University Addresses "Why Quality Training Matters in a Growing Marijuana Industry" in First Blog Post 2Health News:Oaksterdam University Addresses "Why Quality Training Matters in a Growing Marijuana Industry" in First Blog Post 3Health News:Infant cooing, babbling linked to hearing ability, MU researcher finds 2Health News:Florida Hospital Zephyrhills Celebrates Grand Opening of Women’s Health Center 2Health News:Florida Hospital Zephyrhills Celebrates Grand Opening of Women’s Health Center 3Health News:Study questions accuracy of lung cancer screens in some geographic regions 2
... the time in emergency rooms , , TUESDAY, Dec. 18 (HealthDay ... someone is having a heart attack, they are mistaken 9.2 ... that minutes matter with these patients and doctors have to ... say researchers from the Minneapolis Heart Institute Foundation. , "Our ...
... three and older in the United States would carry ... the 2008 University of Louisville Grawemeyer Award in Education. ... nations young children, fill a gap for working families, ... boost the economy, award winners Edward Zigler, Walter Gilliam ...
... led by Mayo Clinic have designed a technique that uses ... cells that spread from primary tumors to other parts of ... shows that this technology could be the basis for a ... appeared in the Dec. 9 online issue of Nature Medicine. ...
... inexpensive infection control measures, hospitals around the world could prevent ... TB), according to a new study in The Lancet by ... Wings for its ability to spread and kill rapidly, XDR ... identified in all regions of the world, including the United ...
... for patients with spinal cord injuries can stimulate ... compensatory changes in the brain, say Canadian researchers. ... function and the ability to walk. , A ... the remarkable benefits of rehabilitation training after a ...
... remains America,s No. 1 killer, AHA says , , TUESDAY, ... death rates in the United States are declining, the ... the nation, according to the American Heart Association. , ... for many people, according to the American Heart Association,s ...
Cached Medicine News:Health News:Diagnosis of Heart Attack Can Be Wrong 2Health News:Researchers train the immune system to deliver virus that destroys cancer in lab models 2Health News:Researchers train the immune system to deliver virus that destroys cancer in lab models 3Health News:Simple strategy could prevent half of deadly tuberculosis infections 2Health News:Intensive training post-spinal cord injury can stimulate repair in brain and spinal cord 2Health News:U.S. Heart Disease Death Rates Falling 2Health News:U.S. Heart Disease Death Rates Falling 3
... cage system provides anterior column support for ... from T1 to L5. The system consists ... polymer cages that are stacked to a ... Peek Carbon fiber reinforced polymer material emulates ...
... is an extrudable, moldable bone void filler that ... anywhere in the skeletal system, including extremities, the ... as a temporary scaffolding for new bone formation. ... X-ray, making healing easier to assess. Boneplast kit ...
... CE mark for its synthetic bone substitute Ossatura. ... of a smart material, i.e. a material that ... of events in the musculo-skeletal system that results ... and improved fusion, and reduces in part or ...
... Cerasorb bone regeneration ... beta-tricalcium phosphate composite ensures ... unique spherical structure maximizes ... Permeability is the most ...
Medicine Products: