There are a number of companies that are developing therapies for the treatment of fibromyalgia.
The Centers for Disease Control and Prevention estimates that about 2% of the population is affected by fibromyalgia (FM). The toll of FM on patients includes an average of 17 missed workdays per year (compared with 6 days for people without FM), hospitalizations about every 3 years, and a greater likelihood of not being able to continue working after hospitalization. Estimated costs of FM are about $6000 per person per year.
One company is Tonix Pharmaceuticals which is conducting a 500-patient Phase 3 Affirm clinical study of Tonmya which is an investigational medication candidate for treating fibromyalgia. It addressed symptoms of fibromyalgia and sleep quality. It is a randomized, double-blind, placebo-controlled, 12-week trial of Tonmya taken sublingually at bedtime daily.
To be eligible for participation in the AFFIRM Clinical Study you must be between the ages of 18 and 75 years old and living with fibromyalgia. To see if you might qualify for the AFFIRM Study, and to be referred to the fibromyalgia study center in your area, the next step is taking the pre-screening questionnaire. To see if you might qualify, and to be connected with the AFFIRM study center in your area, visit here.
Fibromyalgia symptoms can sometimes start after a physical trauma, surgery, infection or significant psychological stress. In other cases, symptoms gradually accumulate over time with no single triggering event.
Women are much more likely to develop fibromyalgia than are men. Many people who have fibromyalgia also have tension headaches, temporomandibular joint (TMJ) disorders, irritable bowel syndrome, anxiety and depression.
In an interview with the National Pain Report, Tonix CEO Dr. Seth Lederman said that as we learn more about fibromyalgia, we are learning it is about more than pain.
“People are beginning to understand that fibromyalgia is not just a pain disorder,” he said. “There’s increasing understanding that it is about much more than pain.”
He said the brain is turned on to be hyper responsive and hyper sensitive to all sorts of sensory information and that fibromyalgia patients have increased sensitivity not only to touch but also to sound, taste, light, and smell. He said, all of their senses are “turned on”.
“If we can improve the sleep quality in fibromyalgia patients, then their other symptoms will improve also,” he said.
The study will run into 2016.
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