Phase III study of S 297995 (naldemedine) shows safety and low incidence of adverse effects in opioid-induced constipation- Shionogi

Shionogi presented positive results of a 52-week, placebo-controlled, phase III study (COMPOSE III) of S 297995 (naldemedine) in treating opioid-induced constipation (OIC) in patients with chronic non-cancer pain (CNCP). The research being found that naldemedine had a low incidence of adverse events, and did not interfere with the analgesic effect of opioids. Results show that, after 52 weeks, naldemedine demonstrated long-term safety, with no statistically significant signs or symptoms of opioid withdrawal. Additionally, treatment with naldemedine demonstrated statistically significant improvement in the frequency of bowel movements per week at each time point measured throughout the study as compared to placebo.

Treatment-emergent adverse events (TEAEs) in patients treated with naldemedine were comparable to patients taking placebo -68.4 percent versus 72.1 percent, respectively. Gastrointestinal side effects that were reported in over 5.0 percent of patients on naldemedine and experienced more frequently than those taking a placebo included, 8.2 percent abdominal pain compared to 3.1 percent on placebo, 11.0 percent diarrhea versus 5.3 percent on placebo and 6.0 percent vomiting as compared to 3.1 percent on placebo. The data was presented at PAINWeek 2016.

Comment: Shionogi previously announced that the New Drug Application (NDA) submitted in the U.S. for naldemedine has been accepted for review. In the U.S., the proposed indication is for the treatment of (OIC) in adult patients with CNCP. The target action date under the Prescription Drug User Fee Act (PDUFA) is March 23, 2017. The company also submitted an NDA in Japan on March 30, 2016 for the proposed indication of the treatment of OIC in adult patients.