Novel Fibromyalgia Treatment Granted FDA Fast Track Designation

Novel Fibromyalgia Treatment Granted FDA Fast Track Designation
Tuscaloosa, Alabama-based Innovative Med Concepts, a biotech company with a pipeline of novel treatments for fibromyalgia and other related conditions that appear to share a common underlying pathophysiology, has announced it has been granted U.S. Food and Drug Administration Fast Track Designation for the development of IMC-1, the lead drug candidate in its pipeline for treating fibromyalgia. IMC-1 previously completed a randomized, double-blind, placebo controlled Phase 2 study (PRID-201), showing to have promise for treating pain and other symptoms of fibromyalgia as well as irritable bowel syndrome (IBS), myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS), chronic neck and back pain, cognitive impairment, and a broad range of other conditions that show strong evidence of sharing the same underlying pathophysiology. IMC-1 has achieved a milestone with completion of the Fibromyalgia Anti-viral Suppression Trial (the FAST study): a double-blind, placebo-controlled Phase 2 proof-of-concept trial designed to evaluate the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia symptoms or recurrence. A group of 143 women from 12 U.S. clinics were diagnosed with primary fibromyalgia as defined by the 2010 College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia. They were evaluated at various intervals for 16 weeks. IMC is currently working with the FDA to meet all the necessary requirements to start the IMC-1 Phase 3 trials for management of fibromyalgia. Fibromyalgia is a common and often debilitating musculoskeletal condition that causes chronic widespread pain and fatigue. It is often accompa
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