Fibromyalgia Treatment Re-Engineered to Reach Unmet Medical Conditions

TONIX Pharmaceuticals is a pharmaceutical company, which specializes in therapy development for challenging disorders of the central nervous system, consisting of, fibromyalgia and post-traumatic stress disorder. TONIX re-engineers declared pharmaceutical agents to design safe, optimal drugs with effectiveness and predictability. Its most advanced product candidates are TNX-102 for FM and TNX-105 for post-traumatic stress disorder (PTSD).

The results of a recent Phase 2a study of bedtime very low dose (VLD) cyclobenzaprine (CBP) for the treatment of fibromyalgia taken by TONIX Pharmaceuticals, Inc., will be released in the November issue of The Journal Of Rheumatology.

The article, entitled “Effects of Bedtime Very Low Dose (VLD) Cyclobenzaprine (CBP) on Symptoms and Sleep Physiology in Patients with Fibromyalgia Syndrome (FM): A Double-blind, Randomized, Placebo-controlled Study,” is authored by Dr. Harvey Moldofsky, Dr. Herbert Harris, Terence Kwong, W. Tad Archambault, Ph.D. and Dr. Seth Lederman.

CBP is TONIX Pharmaceutical’s innovative foundation for treating FB. TNX-102, a commonly prescribed muscle relaxant, is the formulation created from CBP. CBP has already been tested as a daytime treatment for FM, however, a mild case of side effects are likely to show. Data suggests that a course of VLD-CBP taken at bedtime may improve the FMS symptoms during the day with a more acceptable side effect profile.

Key eight-week data from the 36 subjects in the Phase 2a study include:

  • Musculoskeletal pain decreased 26.1% from baseline
  • Tenderness improved 30.1% from baseline
  • HAD Depression decreased 22.2% from baseline
  • Fatigue decreased 14.0% from baseline

The authors conclude, “Although the mechanism by which bedtime VLD CBP acts remains unclear, this study demonstrates the potential for bedtime VLD CBP to relieve pain, reduce fatigue, decrease tenderness, improve mood and improve sleep quality in patients with FM… Bedtime VLD CBP may have an advantage of decreased drowsiness relative to higher daytime doses. In theory, VLD CBP may have other advantages, since it is expected to have less potential for drug interaction or overdose, and may result in increased adherence as a result of once-daily dosing.”

According to the National Institutes of Health, scientists estimate that FM affects 5 million Americans age 18 or older. There are currently three drugs approved for the indication of FM: Lyrica, an analgesic; Cymbalta, an antidepressant and Savella, whose active ingredient is marketed as an antidepressant in Europe. No medicine from the “muscle relaxant” category has been approved for FM. Lyrica, Cymbalta and Savella are all daytime treatments; and no bedtime medication has been approved for this indication.


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