TUSCALOOSA, Ala., Jan. 28, 2016 /PRNewswire/ -- Innovative Med Concepts, LLC, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to the development of IMC-1 for the treatment of fibromyalgia. IMC-1 previously completed a randomized, double-blinded, placebo controlled Phase II study (PRID-201), showing that IMC-1 appears to have promise treating the pain and other symptoms of fibromyalgia.
William Pridgen, M.D., Founder and CEO of Innovative Med Concepts, stated, "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. 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 III trials with IMC-1 in 2017."
Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases. In order to receive Fast Track designation, a product must demonstrate the potential to address an unmet medical need in a serious condition. Companies granted Fast Track designation benefit from greater access to, and more frequent communications with, the FDA throughout the drug development or review process and are allowed to submit New Drug Applications (NDA) on a rolling basis. In addition, Fast Track designation products are eligible for potential accelerated approval and priority review.
Fibromyalgia is a debilitating disorder involving widespread chronic pain along with other symptoms of fatigue, headaches, sleep problems, mood changes and inability to concentrate. According to the National Fibromyalgia Association, an estimated 3-6 percent of people worldwide suffer from the condition, or approximately 10 million in the United States and 220 million worldwide.
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.
This press release contains forward-looking statements. Forward-looking statements can be identified by the use of forward-looking terminology such as "believes," "estimates," "projects," "expects," "may," "intends," "will," "should," or "anticipates" or the negative thereof or similar terminology. These statements appear in a number of places in this press release and include statements regarding IMC's or its management's intent, belief, or current expectations with respect to, among other things: IMC's regulatory approvals and future clinical trials, financial projections regarding IMC's future financial performance and condition, trends affecting IMC's financial condition and results of operations, and IMC's business and growth strategies. Forward-looking statements are subject to risks, uncertainties, and assumptions about IMC.
In light of these risks, uncertainties, and assumptions, IMC can give no assurance that the events disclosed in the forward-looking statements in this press release will in fact transpire. IMC undertakes no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events, or otherwise. IMC expressly disclaims any representation regarding any forward-looking statements. All forward-looking statements in this press release are expressly qualified by the foregoing cautionary statements.
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Innovative Med Concepts Announces Receipt of FDA Fast Track Designation for IMC-1, a Novel Treatment for Fibromyalgia
Jan 28, 2016, 01:24 EST