BLB Solicitors - The Leading Chronic Pain & CRPS Solicitors
BLB Solicitors - The Leading Chronic Pain & CRPS Solicitors
  • Home
  • About Us
    • Andrew Atkinson
    • Bruce Dyer
    • Clare Lowes
    • David Gazzard
    • Mark Tawn
    • Richard Lowes
  • Pain Conditions
    • CRPS Solicitors
    • Fibromyalgia Solictors
    • Myofascial Pain Syndrome Compensation Claim
    • Somatic Symptom Disorder Compensation Claim
    • Neuropathic Pain Compensation Claim
    • Functional Neurological Disorder Compensation
    • Chronic Fatigue Syndrome (ME) Compensation Claim
    • Chronic Pain Syndrome Compensation Claim
  • Unhappy With Your Solicitor?
  • Case Studies
    • Testimonials
  • Blog
  • Contact Us
BLB Chronic Pain News Feb 1st, 2010

New drug treatment for Fibromyalgia accepted by FDA

Jazz Pharmaceuticals have announced that the U.S. Food and Drug Administration (FDA) had accepted for filing the New Drug Application for the prescription drug JZP-6 (sodium oxybate, brand name Xyrem®) for the treatment of fibromyalgia symptoms.

Xyrem is a central nervous system depressant. It is now FDA approved and available only under a special programme for patients with narcolepsy – to support night time drowsiness and thus reduce excessive daytime sleepiness and sudden loss of muscle strength. (It is also a street drug of abuse – known as “GHB.”)

Fibromyalgia studies have focused on the drug’s ability to improve sleep quality, fatigue, and pain.

According to the company’s press release:

“Based on a standard 10-month review, the target date for the FDA to complete its review of the New Drug Application under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.

“The submission is based on a comprehensive clinical development program including results from two Phase III clinical trials. In both trials, sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality. Sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild to 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.”

Richard Lowes
Make an Enquiry

Contact Us

Contact Form

Left Column

Right Column

Centre

 
Sending

Recent Articles

  • Hydroxychloroquine treatment for CRPS
  • Chronic pain may increase the risk of heart attack and stroke
  • How to cope with lockdown when you have chronic pain
  • Can I claim PIP for Fibromyalgia?
  • People suffering CRPS and/or FM report more symptoms than those with other pain conditions

Share this Article

Newsletter Sign-up

* indicates required

You may also like...

  • Jan 1st, 2010
    Controlled breathing can help Fibromyalgia patients
    Read Article
  • Mar 1st, 2010
    Opioid Therapy for chronic pain
    Read Article
View All Related Articles

Get in Touch Today

Contact Form

Left Column

Right Column

Centre

 
Sending

1 Edgar Buildings,
George Street,
Bath, BA1 2DU

01225 462871 01225 445060
Authorised & Regulated by Solicitors Regulation Authority (No. 636644).
©2021 BLB Solicitors  |  Privacy & Terms