ProHealth health Vitamin and Natural Supplement Store and Health
Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help

|
|
|
|

Trending News

New Science Destroys the Saturated Fat Myth

Diet Affects Men’s and Women’s Gut Microbes Differently

New Lyme guidelines promote options and informed choice

Phases of clinical depression could affect treatment

“Worm pill” could ease autoimmune disease symptoms

Eating Baked or Broiled Fish Weekly Boosts Brain Health, Pitt Study Says

Scientists Look for Biomarkers to Improve Treatment of Painful Bladder Condition

New culprit identified in metabolic syndrome

Low vitamin D levels linked to increased risks after noncardiac surgery

Preserving Cognitive Function with Aging

 
Print Page
Email Article

65-center trial of sodium oxybate for fibromyalgia pain completed; second phase III trial still recruiting in US and UK

  [ 14 votes ]   [ Discuss This Article ]
www.ProHealth.com • September 11, 2008


“We anticipate releasing primary efficacy and safety data from the first Phase III clinical trial on schedule in the fourth quarter of this year, and we continue to plan for submission of a New Drug Application to the FDA by the end of 2009." - Samuel Saks, MD

Jazz Pharmaceuticals, Inc. announced on Sept 11 that the final patient has completed participation in the first Phase III pivotal clinical trial of JZP-6 [sodium oxybate, brand name Zyrem®] for the treatment of fibromyalgia.

The JZP-6 Phase III clinical trial program includes two randomized, double blind, placebo-controlled studies. The first study enrolled 550 fibromyalgia patients at 65 centers in the U.S. The second Phase III study is enrolling patients at sites in the U.S. and Europe [UK] (see description at http://www.clinicaltrials.gov).

The primary endpoint for both studies is the change from baseline in pain based on the pain visual analog scale, which the U.S. Food and Drug Administration (FDA) and the European Medicines Agency have indicated is the appropriate primary endpoint.

"Completion of the final patient's participation in this trial is a key milestone in the JZP-6 program," said Samuel Saks, MD, Chief Executive Officer. "The trial results remain blinded to the company, investigators, and patients. We will remain blinded as we conduct analysis of the extensive data set generated by this study. We anticipate releasing primary efficacy and safety data from the first Phase III clinical trial on schedule in the fourth quarter of this year, and we continue to plan for submission of a New Drug Application to the FDA by the end of 2009."

"We appreciate the dedication of the patients, clinical investigators and Jazz Pharmaceuticals employees who are taking part in this important program," Dr. Saks continued.

The JZP-6 clinical program also includes an open-label continuation trial [without placebo comparison] to provide long-term safety data. Enrollment in this trial is ongoing ... open to patients who complete either of the two pivotal Phase III trials.

Sodium oxybate is the active ingredient in Xyrem®, a Jazz Pharmaceuticals product approved by the FDA for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in patients with narcolepsy. Sodium oxybate has not been approved for the treatment of Fibromyalgia.

Source: Jazz Pharmaceuticals, Inc.



Please Discuss This Article:   Post a Comment 



[ Be the first to comment on this article ]




 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Save on Your Next Order

Featured Products

Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
FibroSleep™ by ProHealth FibroSleep™ by ProHealth
The All-in-One Natural Sleep Aid
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%

Natural Remedies

Reversing Neurodegeneration with a New Magnesium Compound Reversing Neurodegeneration with a New Magnesium Compound
Sunshine Vitamin Has D-lightful Health Benefits Sunshine Vitamin Has D-lightful Health Benefits
Protect Against Sun-Induced Skin Aging From The Inside Out Protect Against Sun-Induced Skin Aging From The Inside Out
The Curcumin Revolution: The Curcumin Revolution: "Golden" Ticket to Better Health
Are You Obtaining the Proper Enzymes? Are You Obtaining the Proper Enzymes?

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia 101
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS 101
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE
CONTACT US
PRIVACY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing