Fibro sufferers are all too familiar with implications that their disease is less than legitimate. But fortunately, some researchers in the medical community know otherwise and have been working on novel new approaches to treat the disease. A new drug combo recently received fast track status from the U.S. Food and Drug Administration to treat fibromyalgia—the first drug of its kind to show real promise.
The drug, called IMC-1, is a form of viral suppression. It has already successfully completed phase 2 proof-of-concept trials in a double-blind, placebo-controlled study. The theory behind IMC-1 is that fibromyalgia may be related to the herpes virus lying dormant in body tissue. Treatment is based on the potential effectiveness of a novel combination of viral suppression drugs normally used to suppress herpes.
The study followed 143 women from 12 U.S. clinics. All the women were previously diagnosed with primary fibromyalgia using the criteria defined by the 2010 College of Rheumatology. They were evaluated periodically throughout a 16-week period. IMC is now working with the FDA to meet the requirements to begin the IMC-1 Phase 3 trials.
Researchers noticed that fibromyalgia had a similar cluster of symptoms as other diseases linked to the herpes virus. The most common and uncomfortable fibro symptoms include widespread chronic pain, overwhelming fatigue, sleep problems, and mood problems. Many fibro sufferers also have irritable bowel syndrome, frequent headaches and cognitive impairment (usually called the “fibro fog.”)
Although millions of Americans are affected by fibromyalgia, until recently the medical and scientific community has had few ideas about what causes the chronic illness. Because there is no definitive blood test that can be used to confirm diagnosis, treatment options have also been limited. The lack of effective treatments for fibromyalgia is the reason the FDA granted Fast Track designation to IMC-1. Fast Track Designation is specifically to encourage drug development for diseases that don’t have many treatment options.
Treating fibromyalgia symptoms usually includes antidepressants, painkillers and specific drugs like pregabalin (Lyrica). Diet, exercise and sleep hygiene are also recommended, but most fibro sufferers need more effective and quick-acting relief. Viral suppression with drugs like famciclovir (Famvir) and celecoxib (Celebrex) may be a new treatment that changes the game.