ProHealth fibromyalgia 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

|
|
|

Trending News

Drug Combo in Pridgen Antiviral Fibromyalgia Trial Identified – Some Results Available

7 Fibromyalgia Seasonal Stress Strategies

Blunted Anti-Inflammatory Response to Exercise Increases Fibromyalgia Symptoms

Fibromyalgia Associated with Coronary Heart Disease

Happiness, Gratitude and Appreciation

Cytokine and Chemokine Profiles in Fibromyalgia, RA and Lupus: A Potentially Useful Tool in Differen...

FDA Approves Hysingla ER – Extended-Release Hydrocodone with Abuse-Deterrent Properties

5 Safety Tips for the Holidays for Persons Living with Fibromyalgia and Myofascial Pain Syndrome

Sense of Smell Impaired in Fibromyalgia Patients

Energy Breakthrough - One Fibromyalgia Patient’s Fortuitous Discovery

 
Print Page
Email Article

Effects of Sodium Oxybate for Fibromyalgia Maintained in Long-Term Study

  [ 11 votes ]   [ 2 Comments ]
www.ProHealth.com • December 22, 2013


Note: You may read the full text of this article free HERE.

Editor's comment: In October 2010, the FDA turned down Jazz Pharmaceuticals request for approval of sodium oxybate for the treatment of fibromyalgia, citing safety concerns. They expressed particular concerns about the potential for abuse or misuse of the medication. 

Sodium oxybate is currently approved for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. It's use is monitored by an extremely stringent safety plan – an even more restrictive plan than is used for opioids.  Sodium oxybate is classified as a Schedule III drug and its distribution is restricted through the Patient Success Program.   It can only be purchased from one central, mail-order pharmacy and patients are first required to read a letter and brochure as well as watch a video about the medication.

One of the reasons the FDA has such serious concerns is likely because sodium oxybate, also known as gamma-hydroxybutyrate (GHB), is known to have been used as a date rape drug in the past.  In an effort to address the FDA's concerns, Jazz Pharmaceuticals is conducting additional studies on the safety and efficacy of sodium oxybate for FM.  This study looked at the long-term effectiveness and tolerability of the drug.


Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia.

By Michael Spaeth, et al.

Abstract:


INTRODUCTION: The long-term safety and therapeutic response of sodium oxybate (SXB) in fibromyalgia syndrome (FM) patients were assessed for a combined period of up to 1 year in a prospective, multicenter, open-label, extension study in patients completing 1 of 2 phase 3 randomized, double-blind, controlled, 14-week trials that examined the efficacy and safety of SXB 4.5 g, SXB 6 g, and placebo for treatment of FM.

METHODS: This extension study comprised an additional 38 weeks of treatment and was carried out at 130 clinical sites in 7 countries. Initial entry criteria for the previous 2 double-blind clinical trials required that patients aged ≥ 18 years met the American College of Rheumatology 1990 criteria for FM, had a body mass index (BMI) < 40 kg/m2, and had a score ≥ 50 on a 100-mm pain visual analog scale (VAS) at baseline. All patients began treatment in the extension study with SXB 4.5 g/night (administered in 2 equally divided doses) for at least 1 week, followed by possible serial 1.5 g/night dose increases to 9 g/night (maximum) or reductions to 4.5 g/night (minimum).

RESULTS: Of the 560 FM patients enrolled in this extension study, 319 (57.0%) completed the study. The main reason for early discontinuation was adverse events (AEs; 23.0% of patients). Patients were primarily middle-aged (mean 46.9 ± 10.8 years), female (91.1%), white (91.4%), with a mean duration of FM symptoms of 9.9 ± 8.7 years.

  • Serious AEs were experienced by 3.6% of patients.

  • The most frequently reported AEs (incidence ≥ 5% at any dose or overall) were nausea, headache, dizziness, nasopharyngitis, vomiting, sinusitis, diarrhea, anxiety, insomnia, influenza, somnolence, upper respiratory tract infection, muscle spasms, urinary tract infection, and gastroenteritis viral.

  • Maintenance of SXB therapeutic response was demonstrated with continued improvement from controlled-study baseline in pain VAS, Fibromyalgia Impact Questionnaire (FIQ) total scores, and other measures.

  • Responder analyses showed that 68.8% of patients achieved ≥ 30% reduction in pain VAS and 69.7% achieved ≥ 30% reduction in FIQ total score at study endpoint.

CONCLUSIONS: The long-term safety profile of SXB in FM patients was similar to that in the previously reported controlled clinical trials. Improvement in pain and other FM clinical domains was maintained during long-term use.

Source: Arthritis Research & Therapy, November 11, 2013. By Michael Spaeth, Cayetano Alegre, Serge Perrot, Youyu Grace Wang, Diane R Guinta, Sarah Alvarez-Horine, Irwin Jon Russell and the Sodium Oxybate Fibromyalgia Study Group.




Please Discuss This Article:   Post a Comment 

Better than what's out there
Posted by: MarcieRose
Jan 29, 2014
The response to this compound is equal to or better than current approved treatments. Further, the pain reductions seen may well be due to the increase in deep, restorative sleep that Sodium oxybate promotes. There simply has to be a way to get the FDA to reconsider this compound.
Reply Reply
 
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 Nutritional Supplement Orders

Featured Products

Fibro Freedom™ Fibro Freedom™
Soothes, strengthens & revitalizes
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 your brain needs for detox & sharpness
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
FibroSleep™ by ProHealth FibroSleep™ by ProHealth
The All-in-One Natural Sleep Aid
Optimized Curcumin Longvida® by ProHealth Optimized Curcumin Longvida® by ProHealth
Supports Cognition, Memory & Overall Health

Natural Remedies

Running on Empty? Fuel Up with NADH Running on Empty? Fuel Up with NADH
The Brain Boosting and Fatigue Fighting B-12 The Brain Boosting and Fatigue Fighting B-12
Repair Damaged Mitochondria and Reduce Fatigue Up to 45% Repair Damaged Mitochondria and Reduce Fatigue Up to 45%
Three-Step Strategy to Reverse Mitochondrial Aging Three-Step Strategy to Reverse Mitochondrial Aging
Why Berries Offer a Rainbow of Health Benefits Why Berries Offer a Rainbow of Health Benefits

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