Premier 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 disease. We look forward to completing the FDA regulatory process so that we can get our products into this vast market and relieve suffering as soon as possible. We intend to capture a share of this ten billion dollar annual market.”
The drug combination Feldetrex is intended to treat the symptoms that affect patients who suffer from fibromyalgia, which include chronic muscle pain, painful tender points, and morning stiffness, as well as sleeping disturbances, fatigue and anxiety. If approved, the drug may help in the symptom management of the disease that affects between three and five percent of the world population.
“We are very excited about this drug’s ability to relieve the symptoms of fibromyalgia without many of the negative side-effects associated with many of the current drug treatments,” added the chair of the scientific advisory board of the company, Mitchell S. Felder M.D.
Founded in 2010, Premier Biomedical is dedicated to studying and developing therapeutic options for the treatment of several conditions, including not only fibromyalgia, but also cancer sepsis and multiple sclerosis. The company’s technology and drugs have already been granted licenses and multiple provisional patents in the United States, as well as a PCT Europe National Patent.
The FDA has only approved therapies for fibromyalgia in 2007, but the agency also recently provided guidance to Tonix Pharmaceuticals Holding Corp. for the continuation of their phase 3 clinical trials, a study dedicated to evaluating TNX-102 SL, which is also intended to treat the disease.
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