Fibromyalgia Drug Study Enrollment Open

Fibromyalgia Drug Study Enrollment Open

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.

Do you suffer from fibromyalgia? Tell us your story editor@nationalpainreport.com

Follow on Twitter

@NatPainReport

@edcoghlan

@TonixPharma

Authored by: Ed Coghlan

There are 6 comments for this article
  1. Karen at 8:48 pm

    Was diagnosed in 1982 but didn’t get disability until 1999. So very dissatisfied with the way I have been treated by the medical professionals! They just think you are depressed… Help

  2. Marla at 8:50 pm

    We need something that works. If medical marijuana relieves pain better than meds, it should be legal to prescribe in Texas. Until I’m prescribed something that works, I’m up for the study.

  3. Rosetta at 7:17 pm

    I know there is not a study in my area but maybe there will be soon. I was diagnosed with fibro about 8 years ago. I also have irritable bowel syndrome, chronic fatigue syndrome, and osteo arthritis and chronic depression. I’m 51 years old and have worked since I was 15. In 2014 I had to stop working because I was missing a lot of days. The pain and just not being able to move or focus took it’s toll. Doctors tried different meds for fibro but I couldn’t take them. Depression med cymbalta helps some. Living on one income for over a year has been hard. Had to sell our house and move. Would love to find something that works for this so I could go back to WORK!

  4. Tammy Holden at 9:28 pm

    There were no studies for my local area. I have suffered with fibromyalgia for approximately 15 years. Three years ago I had to leave my job and apply for disability. Most of my doctors appointments are between 2 to 3 hours from my home. Please reconsider me for this study. I want to Contribute in finding something that will help this debilitating illness. I can go to Birmingham, Alabama, Nashville, Tennesse, Memphis, Tennessee, Northern Mississippi/Alabama state line areas, even close to the Noethern Alabama/Georgia state line. Please reconsider and find me a place in this study.

  5. santanu modak at 9:28 am

    my wife recently diagnosed as fibromyalgia.what should be the plan of treatment?

  6. Veronica at 2:33 am

    It said I didn’t qualify for the fibromyalgia study, but I see there is 1 being conducted in WI in Kenosha. What these study people don’t realize is that those of us that live up here in northern WI have traveled to Milwaukee, Marshfield, Green Bay, Wausau, etc., for doctor appointments that aren’t available in our area. We go 200 miles 1 way, and think nothing of it. I really want to be in this study, and am willing to travel. I have suffered for so many years that if there is possibly something else out there that may help me, and enable me to work again, I want it! Please reconsider me for the study. Thank you!!
    Veronica Clark
    Wabeno, WI 54566