During the year following my fibromyalgia diagnosis, my rheumatologist prescribed five different drugs in an attempt to relieve my pain.
None of them worked.
The current fibromyalgia drugs on the market are notoriously ineffective. I remember my rheumatologist sharing a surprising statistic that I’ve since verified through my own research: The most effective fibromyalgia drugs only provide at least a 50 percent reduction in pain in about one-third of patients.
We desperately need better treatments, and drug companies are anxious to deliver them. Two new fibromyalgia drugs are currently in clinical trials, and a third one will be tested next year.
Two of these prospective treatments are cousins to drugs already on the market, and one takes a completely unique approach to fibromyalgia. I’ll start with that one first.
The U.S. Food and Drug Administration (FDA) has fast tracked IMC-1, a combination of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, for a Phase III trial next year.
Dr. William “Skip” Pridgen, the combo’s discoverer, believes the HSV1 virus, commonly associated with cold sores, may be a culprit in fibromyalgia. He developed this theory while treating the gastrointestinal issues of fibromyalgia patients in his growing surgical practice in Tuscaloosa, Alabama.
Pridgen noticed patients’ symptoms seemed to wax and wane over time and speculated these flares may be caused by the activation of an undetected virus. He tested his theory by prescribing common antiviral medications and noticed some slight improvement among patients.
Around the same time, he began giving fibromyalgia patients samples of Celebrex, hoping the anti-inflammatory would reduce their overall pain. The patients who took both the antiviral and the Celebrex began reporting substantial improvements in their fibromyalgia symptoms.
In 2014, Pridgen and his research team conducted a phase II study involving 143 fibromyalgia patients at 12 U.S. clinics. Patients either received IMC-1 or a placebo. After 16 weeks, 37.9 percent of patients reported a 50 percent or greater reduction in pain. That’s slightly better than Cymbalta, the most effective of the three FDA-approved fibromyalgia drugs. Side effects were low, with more patients from the placebo group dropping out of the trial due to adverse reactions than those taking IMC-1.
“We had pain reduction levels that rivaled or were comparable to other fibromyalgia drugs,” Pridgen said. “It wasn’t just that we reduced their pain. In all the measures we looked at [including fatigue, anxiety, headaches, TMJ, etc.], we seem to have an impact overall.
“We’re radically different [from other fibromyalgia drugs],” Pridgen continued. “Instead of just trying to reduce pain perception, we think we’ve discovered what is at the root cause [of fibromyalgia].”
Pridgen expects even better results from next year’s phase III trial because it will use the dosage he’s been perfecting in his practice for the past six years. Phase II used a lower, less effective dose, he said.
Phase III may enroll up to 1,200 patients at around 60 sites, some of which could be international. Several major pharmaceutical companies have already expressed interest in IMC-1, and a new drug could be on the market within three years.