Approval Status: Approved March 2017
Specific Treatments: opioid-induced constipation
Therapeutic Areas Gastroenterology
Symproic (naldemedine) is an opioid antagonist.
Symproic is specifically indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
Symproic is supplied as a tablet for oral administration. The recommended dosage is 0.2 mg once daily with or without food.
The FDA approval of Symproic was based on two replicate, 12-week, randomized, double-blind, placebo-controlled trials (Study 1 and Study 2) in which Symproic was used without laxatives in patients with OIC and chronic non-cancer pain. In both studies, OIC was confirmed through a two-week run in period and was defined as no more than 4 spontaneous bowel movements (SBMs) total over 14 consecutive days and less than 3 SBMs in a given week with at least 25% of the SBMs associated with one or more of the following conditions: (1) straining; (2) hard or lumpy stools; (3) having a sensation of incomplete evacuation; and (4) having a sensation of anorectal obstruction/blockage. A total of 547 patients in Study 1 and 553 patients in Study 2 were randomized in a 1:1 ratio to receive Symproic 0.2 mg once daily or placebo for 12 weeks. Study medication was administered without regard to meals. The efficacy of Symproic was assessed in Studies 1 and 2 using a responder analysis. A responder was defined as a patient who had at least 3 SBMs per week and a change from baseline of at least 1 SBM per week for at least 9 out of the 12 weeks and 3 out of the last 4 weeks in Studies 1 and 2. Study 1: Symproic arm: 130 subjects (48%) were responders versus placebo arm: 94 subjects (35%) (p=0.0020). Study 2: Symproic arm: 145 subjects (53%) were responders versus placebo arm: 92 subjects (34%) (p<0.0001).
Adverse effects associated with the use of Symproic may include, but are not limited to, the following:
- abdominal pain
Mechanism of Action
Symproic (naldemedine) is an opioid antagonist with binding affinities for mu-, delta-, and kappa-opioid receptors. Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids.
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