Shionogi and Purdue Pharma have announced that the FDA has approved Symproic® (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Symproic is currently a Schedule II controlled substance because it is structurally related to naltrexone. Shionogi Inc. submitted a petition for the descheduling of Symproic, or removal of the controlled substance classification, to the U.S. Drug Enforcement Administration, which is currently under evaluation. Symproic will be jointly launched and commercialized in the U.S. with Purdue Pharma and is expected to be commercially available mid-summer.