Emotional Trauma May Not Lead to Fibromyalgia, Researchers Say

TONIX Pharmaceuticals developing treatment for Fibromyalgia (FM) sufferers with focus on improving sleep quality.

The medical community has not yet identified the exact cause of fibromyalgia syndrome (FM)-whose symptoms can include widespread pain, headaches, arthritis, muscle spasm, tingling, balance problems and more-but multiple factors are likely involved. Emotional trauma has long been considered one potential factor, but a new report, published in the January 17, 2013 issue of Psychology, Health & Medicine, casts doubt. The researchers, from the University of Lisbon, found no link between traumatic life events and measures of health, including physical health, mental health, pain load and overall disability.

No matter what the actual causes of FM, new and more effective treatments are needed. The current standard of care includes three FDA-approved medications, but most patients remained unsatisfied. While widespread pain is the signature complaint in fibromyalgia, the key to alleviating pain and other symptoms may be a restful night's sleep. The National Pain Foundation estimates that 90 percent of FM patients have sleep problems. Poor sleep quality has been shown to be associated with FM pain, and whenever sleep is perceived as restful, patients report substantial improvement in their daytime symptoms. However, there is no FDA-approved treatment for addressing the sleep problem in fibromyalgia patients and prescription sleep drugs don't work.

TONIX Pharmaceuticals Holding Corp., a NYC-based publicly traded company, believes there is an unmet need for a non-habit forming, relatively safe, pharmaceutical treatment for FM and is developing one such drug that focuses on improving sleep quality as the key to treatment. The company is developing a treatment involving cyclobenzaprine, a compound that is FDA approved as a muscle relaxant but is sometimes prescribed by physicians as a slow-acting sleep aid in FM. The company is studying whether or not very low-dose cyclobenzaprine, administered as an under-the-tongue tablet at bedtime, can ensure a more restful, quality sleep, which in turn will alleviate the pain and mood symptoms experienced by FM patients during the day. The treatment has already been shown to improve FM outcomes in a Phase 2a clinical study involving 36 patients, including reductions in musculoskeletal pain, tenderness, fatigue and altered mood. TONIX's first pivotal trial for its treatment is set to begin in 2013.

A safe and effective treatment that promotes restful sleep could hold the potential to improve the lives of millions of people affected by fibromyalgia.

More info at www.tonixpharma.com

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