A 4th drug for fibromyalgia clears another hurdle

Written by Anthony Hardie, 91outcomes

(91outcomes.blogspot.com) - In today's news, Jazz Pharmaceuticals Inc. (JAZZ) said on late Wednesday, June 24, that preliminary results from a second Phase III clinical trial of its fibromyalgia treatment sodium oxybate (JZP-6) further confirmed positive results from an earlier study. The new study showed patients' significantly improved ability to perform daily tasks, along with reduced chronic fatigue.

Shares of Jazz stock quickly soared by 26% to $4.10 in after-hours trading, showing the market's interest in drugs for fibromyalgia, a chronic pain condition believed to affect an estimated two percent of Americans, including thousands of veterans of the 1991 Gulf War.

"Fibromyalgia is a chronic illness, characterized by widespread pain, unrefreshing sleep, chronic fatigue, and psychological distress," said I. Jon Russell, M.D., Ph.D. in a Jazz press release. Russell is the lead investigator in the first Phase III study and Associate Professor of Medicine, Division of Clinical Immunology and Rheumatology, and Director, University Clinical Research Center, University of Texas Health Science Center at San Antonio.

"Sodium oxybate has shown a positive effect on a number of the symptoms of fibromyalgia, and thus could have a significant impact on patients' quality of life," said Russell in the prepared statement.

If ultimately approved by FDA for the treatment of fibromyalgia, sodium oxybate would be the fourth FDA approved drug for the disease.

Since 2008, the three drugs approved by the FDA for the treatment of fibromyalgia include:

• Lyrica (pregablin)
• Cymbalta (duloxetine HCI)
  
• Savella (milnacipram HCI)
  

According to the Jazz release:

About Sodium Oxybate
Sodium oxybate is the sodium salt form of gamma-hydroxybutyrate, an endogenous neurotransmitter and metabolite of GABA. While the precise mechanism of action is unknown, the effects may be mediated in part through interaction with GABA(B) and GHB receptors. Sodium oxybate is the active ingredient in XYREM(R), approved by the FDA and marketed by Jazz Pharmaceuticals in the U.S. for the treatment of excessive daytime sleepiness and cataplexy (the sudden loss of muscle tone) in adult patients with narcolepsy. The American Academy of Sleep Medicine recommends sodium oxybate as a standard of care for the FDA-approved indications. UCB markets XYREM(R) (sodium oxybate oral solution) in Europe, where it is approved by the EMEA for the treatment of narcolepsy with cataplexy in adult patients under a license from Jazz Pharmaceuticals. Most commonly reported adverse drug reactions in narcolepsy patients are dizziness, nausea and headaches. Sodium oxybate has the potential to induce respiratory depression and neuropsychiatric events. Sodium oxybate has not been evaluated by regulators for the treatment of fibromyalgia and is not approved for this use.
About Fibromyalgia
Fibromyalgia, a chronic condition characterized by widespread pain, affects 0.5% - 5% of adults worldwide. Fibromyalgia is believed to be a central nervous system condition, resulting from neurological changes in how the brain perceives and responds to pain. In addition to pain, the main symptoms are fatigue, disturbed sleep and morning stiffness. The exact causes of fibromyalgia are unknown. It may be triggered by physical trauma, emotional stress, chronic pain or infection. Genetics, neurochemicals that affect pain modulation, neurohormones and sleep physiology abnormalities are thought to play a role. Research also has suggested a relationship between sleep and pain. Fibromyalgia patients experience a high prevalence of sleep problems, including a reduction in non-restorative or deep sleep.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals (Nasdaq: JAZZ) is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. For further information see http://www.jazzpharmaceuticals.com/.