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Feb. 22, 2013 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that its flupirtine sublicensee, Meda AB (Meda), has received a green light from the Food and Drug Administration (FDA) to conduct a Phase II proof of concept study for the treatment of fibromyalgia as reported in Meda's 2012 year-end report. Meda has announced that the randomized, double-blind, placebo and active-controlled study of patients with fibromyalgia will be conducted at 25 clinics in the U.S.
May 2010, the Company entered into an agreement with
Sweden-based Meda granting exclusive sublicense to all of its patents and pending patents covering the use of flupirtine for fibromyalgia in the U.S.,
Japan. Meda assumed all future development costs for the commercialization of flupirtine for fibromyalgia. Synthetic Biologics received an upfront payment and is entitled to future milestone payments, plus royalties.
"We are pleased to share Meda's update on the status of its clinical development program of flupirtine for fibromyalgia," stated
Jeffrey Riley, Chief Executive Officer at Synthetic Biologics. "We believe Meda's experience with flupirtine outside of the U.S. will help bring this potential new class of treatment to the millions of people that suffer from fibromyalgia in the U.S."
About Fibromyalgia and Flupirtine
Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. Fibromyalgia affects an estimated 3-6% of the population worldwide, including an estimated 10 million patients in the U.S. There are presently three products approved for this indication in the U.S. – Lyrica®, Cymbalta® and Savella®. Flupirtine is differentiated from these products in that it employs a unique mode of action.