Shionogi and Purdue announced that the Food and Drug Administration (FDA) has approved Symproic (naldemedine) tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

Symproic has been scheduled as a CII controlled substance due to its structural relation to naltrexone. The Company’s petition for the descheduling of Symproic is currently being evaluated by the Drug Enforcement Agency (DEA). Symproic functions as a peripherally-acting mu-opioid receptor antagonist (PAMORA) in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. 

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The approval was supported by data from the COMPOSE program that consisted of 3 studies: COMPOSE I, COMPOSE II, and COMPOSE III. COMPOSE I and II were 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies; COMPOSE III was a 52-week, randomized, double-blind, placebo-controlled, long-term safety study.

Symproic will be available as 0.2mg strength tablets in 90-count bottles. It is anticipated to launch mid-summer of 2017.

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