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

Inflammation Disrupts Memory - What Can You Do to Protect Your Brain?

All About Ginkgo Biloba: Benefits of This Timeless Herbal Supplement

Yarrow Oil: Here's Why It Deserves a Place in Your First-Aid Kit

Artificial sweeteners linked to risk of weight gain, heart disease and other health issues

Trial Finds Reduction in Depressive Symptoms Following Magnesium Supplementation

Vitamin D supplement use associated with lower risk of breast cancer

Carnitine deficiency suggested as contributor to autism

Hop Oil: A Safe Sleep Aide

White Camphor Oil: The Purest Camphor Oil

Lutein — An Important Nutrient for Eye and Brain Health

 
Print Page
Email Article

FDA Panel Nixes Xyrem for Fibromyalgia, 20 to 2: Here’s what they heard in their deliberations

  [ 12 votes ]   [ Discuss This Article ]
www.ProHealth.com • August 22, 2010


After various experts made their case on Friday, Aug 20, an FDA advisory committee voted 20 to 2 against issuing a positive recommendation for Jazz Pharmaceuticals’ narcolepsy drug Xyrem (aka “the date rape drug”) as a therapy for fibromyalgia symptoms (for this purpose, dubbed JZP-6). For background, see for example “Treatment of the narcoleptiform sleep disorder in chronic fatigue syndrome and fibromyalgia with sodium oxybate.”

The key sticking point for the panel was fear that broader approval for Xyrem/JZP-6 might “create too many opportunities for abuse & misuse.” A further question being whether it outperforms in some way the three other drugs OK’d for prescription to FM patients.

What the Panel Heard on Behalf of Xyrem/JZP-6 for Fibromyalgia

Reporter Adam Feuerstein reported minute-by-minute on the gist of the presentations in a blog published by TheStreet.com that was joined by more than 400 patients, investors, and clinicians. To read this informative narrative, go to “Jazz Pharma: FDA Panel Live Blog.” Allow time for it all to load, and scroll down at your own speed.

Topics presented by various experts, such as physicians who conducted the various Xyrem studies, and National Fibromyalgia Association President Lynne Matallana, covered:

• History of the drug’s performance in narcolepsy patients.

• Fibromyalgia patients’ need for help with symptoms.

• Design of the Xyrem/FM trials, and efficacy data.

• How the drug helps patients by helping sleep, which in turn may help other symptoms

• FM doctors speak on behalf of the drug, patients’ need for treatment, and drug’s benefit

• Dosing issues (patients take one dose at bedtime & another 3-4 hours later)

• Nature & frequency of adverse events with Xyrem.

• The proposed REMS (risk evaluation and mitigation strategies) plan for Xyrem/JZP-6 if OK’d as a drug for FM.

Commenting on the FDA panel’s decision not to recommend the drug as a Fibromyalgia therapy, Feuerstein said, with the “abuse/misuse issue that loomed large in the room… I think Jazz would have stood little chance of getting Xyrem approved for narcolepsy today.”

The FDA will consider the panel’s recommendation, and issue its final decision on Oct 11.




Post a Comment

Featured Products From the ProHealth Store
FibroSleep™ Mitochondria Ignite™ with NT Factor® Ultra ATP+, Double Strength


Article Comments



Be the first to comment on this article!

Post a Comment


 
NAD+ Ignite with Niagen

Featured Products

Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%

Natural Remedies

The Super Antioxidant for Brain, Joint and Heart Health The Super Antioxidant for Brain, Joint and Heart Health
Undenatured Type II Collagen - Chicken Soup for Your Joints Undenatured Type II Collagen - Chicken Soup for Your Joints
Research Links Green Tea to Weight Loss Research Links Green Tea to Weight Loss
The Remarkable Benefits of Reishi Medicinal Mushrooms The Remarkable Benefits of Reishi Medicinal Mushrooms
Ubiquinol - A More Advanced Form of the Energy Producing Nutrient CoQ-10 Ubiquinol - A More Advanced Form of the Energy Producing Nutrient CoQ-10

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

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

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

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map