Date: 2016-02-19
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Academy of Pain Medicine (AAPM) 2016 Annual Meeting in Palm Springs, CA
Company: Shionogi (Japan)
Product: naldemedine
Action
mechanism: peripherally-acting mu-opioid receptor antagonist (PAMORA). Naldemedine is an investigational, oral, peripherally acting mu-opioid receptor antagonist (PAMORA) being studied for the treatment of OIC.
Disease: opioid-induced constipation (OIC)
Therapeutic area: Digestive diseases - Gastrointestinal diseases - Inflammatory diseases
Country:
Trial
details: The COMPOSE program is a global comprehensive development program comprised of seven clinical studies being conducted in patients with OIC with cancer or chronic non-cancer pain. COMPOSE II is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The study was designed to evaluate the efficacy and safety of naldemedine therapy, versus placebo, in 553 patients receiving chronic opioid therapy for at least three months, and who experience OIC accompanied by chronic non-cancer pain.
Latest
news: * On February 19, 2016, Shionogi announced pivotal phase III study (COMPOSE I) results showing that once-daily treatment with naldemedine significantly improved opioid-induced constipation compared to placebo in patients with chronic non-cancer pain. The data, which are being presented (poster # 192) 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. The study found that for the primary endpoint 47.6 percent of patients taking an oral, once-daily 0.2 mg 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 percent of patients on placebo over 12 weeks. Additionally, naldemedine significantly improved all key secondary endpoints, which included a significant increase in complete SBMs (CSBMs) per week, as well as SBMs without straining per week, from baseline to the last two weeks of the study period, as compared to placebo. Abdominal pain and diarrhea were the only treatment related adverse events that were reported in five percent or more of patients, with abdominal pain reported in 6.3 percent of patients on naldemedine vs. 1.8 percent on placebo, and diarrhea reported in 6.6 percent of patients on naldemedine vs. 2.9 percent on placebo. * On August 3, 2015, Shionogi announced that once-daily naldemedine met its primary and secondary endpoints in a phase III study (COMPOSE II) for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. This is the third Phase III trial in which naldemedine met its primary and key secondary endpoints. Study results showed that a 0.2 mg tablet of naldemedine given once daily significantly improved the frequency of spontaneous bowel movement (SBM) compared with placebo over 12 weeks. Naldemedine was generally well-tolerated with the most commonly reported side effects being gastrointestinal disorders. Shionogi previously announced that naldemedine met its primary and key secondary endpoints in COMPOSE I and COMPOSE IV. COMPOSE I evaluated the efficacy and safety of naldemedine therapy, versus placebo, in patients receiving chronic opioid therapy, who experience OIC accompanied by chronic non-cancer pain. COMPOSE IV was conducted in Japan and evaluated the efficacy and safety of naldemedine therapy, versus placebo, in patients receiving chronic opioid therapy for cancer pain and who experience OIC.
