The safety profile was very encouraging. Despite the celecoxib component of IMC-1, common gastrointestinal (29.0% vs 42.5%) and nervous system (17.4% vs 23.3%) treatment emergent adverse events were reported less frequently in the IMC-1 group than in the placebo treated group. Overall, Study completion rates favored IMC-1 (82.6% vs 60.8%), showing a positive impact on adherence to therapy.
The results of this study suggest that IMC-1 is safe and efficacious in the treatment of the symptoms of fibromyalgia. Based on a novel mechanism of action and the study results showing efficacy on a range of important outcome measures, improved retention rates, decreased adverse event rates, IMC-1 may represent an effective and differentiated treatment for fibromyalgia sufferers.
After completion of the PRID-201 trial, the FDA granted IMC-1 fast track status, finding that FM is a serious disease with a large unmet need and that IMC-1 has the potential to meet that need. IMC plans to start a Phase 3 randomized, double-blinded, multi-center, factorial pivotal trial, using an improved IMC-1, later this year.
About Innovative Med Concepts
Innovative Med Concepts, LLC, is a biotech company developing novel treatments for fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), irritable bowel syndrome and other related conditions. On the Web: http://innovativemedconcepts.com.
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SOURCE Innovative Med Concepts, LLC