Naldemedine Phase III study shows significant improvement for OIC patients

23 February 2016

Japanese drugmaker Shionogi (TYO: 4507) has announced pivotal Phase III study (COMPOSE I) results showing that once-daily treatment with naldemedine significantly improved opioid-induced constipation (OIC) compared to placebo in patients with chronic non-cancer pain.

The data, which was presented at the American Academy of Pain Medicine (AAPM) 2016 Annual Meeting in Palm Springs, CA, also showed that naldemedine was generally well tolerated, with a low incidence rate of gastrointestinal (GI) related side effects.

Naldemedine is an investigational, oral, peripherally acting mu-opioid receptor antagonist (PAMORA) being studied for the treatment of OIC. The study found that for the primary endpoint 47.6% of patients taking an oral, once-daily 0.2mg tablet of naldemedine experienced an increase in the frequency of spontaneous bowel movements (SBMs) from baseline for at least nine out of 12 weeks (including three out of the last four weeks) compared with 34.6% of patients on placebo over 12 weeks.

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