Symproic regulatory update

FDA and Japan approved Symproic naldemedine from Shionogi to treat opioid-induced constipation (OIC). It is indicated in the U.S. in adults with chronic non-cancer pain. Shionogi said the U.S. Drug Enforcement Administration (DEA) is reviewing the pharma’s petition to deschedule the oral peripheral mu opioid receptor (MOR; OPRM1) antagonist as a Schedule II controlled substance. Shionogi and Purdue Pharma L.P. (Stamford, Conn.) expect to launch the product in the U.S. in mid-summer. Purdue has rights to co-commercialize Symproic in the U.S. (see BioCentury, Dec. 30, 2016)...