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# Shionogi/Purdue Drug OK’d for Opioid-induced Constipation
- URL: https://www.fdaweb.com/shionogi-purdue-drug-okd-for-opioid-induced-constipation/
- Published: 2017-03-24T12:00:00.000Z
- Updated: 2026-09-14T22:13:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138291

FDA has approved a Shionogi Inc. and Purdue Pharma NDA for Symproic (naldemedine) 0.2 mg tablets, a once-daily oral peripherally-acting mu-opioid receptor antagonist for treating opioid-induced constipation in adult patients with chronic non-cancer pain. The companies say 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 (DEA), which is currently under evaluation.” Approval was based on data from the COMPOSE program, (COMPOSE I, COMPOSE II and COMPOSE III studies).