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Fast track designation granted by FDA for new fibromyalgia treatment
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Innovative Med Concepts LLC announced it has been granted fast track designation by the FDA for the development of its IMC-1 treatment for fibromyalgia, according to a company press release.
“We are pleased that the FDA has granted fast track status to IMC-1, as it demonstrates their recognition of this condition as a significant unmet medical need,” William Pridgen, MD, founder and chief executive officer of Innovative Med Concepts, said in the release. “IMC-1 has a novel mechanism of action designed to suppress chronic tissue-resident herpes virus, which may have a role in triggering or maintaining symptoms of fibromyalgia. IMC-1 is a fixed-dose combination using proprietary doses of famciclovir, an anti-viral nucleoside analog, and celecoxib, a COX-2 inhibitor that also possesses unique anti-viral activity. Suppressing latent herpes viruses may significantly improve fibromyalgia-related symptoms. We are currently meeting the development requirements to begin phase 3 trials with IMC-1 in 2017.”
A phase 2, randomized, double-blind, placebo-controlled study with IMC-1 showed results with the treatment of pain and other fibromyalgia symptoms, according to the company. Fast track status allows greater access to and more frequent communication with the FDA for treatments that serve an unmet need.
Reference:
http://innovativemedconcepts.com