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June 12, 2014
14:44 EDTSCMPSucampo issues statement regarding AADPA meeting's vote
Sucampo Pharmaceuticals issued the following statement regarding the Anesthetic and Analgesic Drug Products Advisory Committee meeting's vote: "As a chloride channel activator, AMITIZA has a different mechanism of action than the peripherally acting mu-opioid receptor antagonists and is approved by the U.S.FDA to treat opioid induced constipation. AMITIZA has been prescribed over eight million times over more than eight years and has a well-tolerated safety profile, with no cardiovascular precautions or warnings. FDA did not require Sucampo to reevaluate our clinical data for cardiovascular risks, as they did for the PAMORAS, and AMITIZA was therefore not a participant in this week's Advisory Committee," said Peter Greenleaf, CEO of Sucampo. "We believe the outcome of today's Advisory Committee further demonstrates the FDA's awareness that safety, specifically the potential cardiovascular safety associated with the PAMORAS class of compounds, is paramount in assessing alternative therapies for OIC, which is a severe condition that affects 40-80 percent of the estimated 250 million patients who receive prescriptions for opioids each year for non-cancer pain. OIC is still widely under-identified and under-managed, and we believe that potential new entrants to the market can help increase overall awareness of the condition. We remain committed to maximizing AMITIZA's potential and to bringing it to physicians and patients worldwide for the treatment of OIC."
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17:33 EDTSCMPSucampo files patent infringement suit against Dr. Reddy's Labs
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