Activate Now
 
ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Acupuncture used in clinical settings reduced symptoms of menopause

Benefits of Coconut Oil Are Undeniable

How Awesome Is Ashwagandha?

SURVEY RESULTS: Should Opioids Be Restricted for Chronic Illness?

CoQ10 supplementation associated with lower pro-inflammatory factors in randomized trial

Clinical trial demonstrates success of low FODMAP diet

Research Demonstrates Superiority of Krill Oil Compared to Fish Oil

Vitamin nicotinamide riboside protects mice from diabetes complications

What’s so Remarkable About Rosemary?

Vitamin-mineral supplement prevents brain cell loss in recent research

 
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.




Post a Comment

Featured Products From the ProHealth Store
Mitochondria Ignite™ with NT Factor® Vitamin D3 Extreme™ Ultra EPA  - Fish Oil

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


 
All Natural Deodorants

Featured Products

Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

Fatigue & Fibro Fog: Could You Have a B-12 Deficiency? Fatigue & Fibro Fog: Could You Have a B-12 Deficiency?
How to Jump-start and Sustain Energy Production in CFS How to Jump-start and Sustain Energy Production in CFS
Research Links Green Tea to Weight Loss Research Links Green Tea to Weight Loss
Coping When Colds or Flu Catch Up with You Coping When Colds or Flu Catch Up with You
Coconut Oil - Healthy Gifts from the 'Tree of Life' Coconut Oil - Healthy Gifts from the 'Tree of Life'

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler

· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE AND SAVE 15% NOW*
Be the first to know about new products, special discounts and the latest health news. *New subscribers only

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2016 ProHealth, Inc. All rights reserved. Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map