Premier Biomedical to Submit Fibromyalgia Therapy to FDA

Premier Biomedical to Submit Fibromyalgia Therapy to FDA
Premier BiomedicalPremier Biomedical Inc. has announced it will submit an application to the U.S. Food and Drug Administration (FDA) with the purpose of selling an exclusively licensed and patented drug therapy designed for the treatment of fibromyalgia. The company is now expecting to discuss with the agency the requirements needed regarding both clinical studies and possible marketing approval to commercialize Feldetrex, as announced in a press release. Premier Biomedical hopes that Feldetrex, a drug combination of compounds approved by the FDA that was issued a patent last October, will be able to provide relief to fibromyalgia patients in the American market. The company currently holds exclusive rights to the patent of the drug, which, if approved to enter pharmacies, will compete with a series of other brand-name drugs that exceed $10 billion in annual sales combined. "This is our second in a series of filings we have made with the FDA," explained the president and CEO of Premier Biomedical, William A. Hartman. "Those suffering from fibromyalgia know how painful debilitating and frustrating it can be to try and manage the symptoms of this widespread diseas
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