Naldemedine is Safe, Well Tolerated in Treatment of Opioid-Induced Constipation
Patients who took naldemedine reported diarrhea, abdominal pain, and nausea.
|The following article is part of conference coverage from the PAINWeek 2018 conference in Las Vegas, Nevada. Clinical Pain Advisor's staff will be reporting breaking news associated with research conducted by leading experts in pain medicine. Check back for the latest news from PAINWeek 2018.|
LAS VEGAS — Naldemedine (NAL), a peripherally acting μ-opioid receptor antagonist, was well tolerated and associated with mild to moderate treatment-emergent adverse events (TEAEs) in patients with non-cancer pain treated for opioid-induced constipation, according to a study presented during the 2018 PAINWeek conference, held September 4-8.
In the study, researchers reviewed three phase 3 randomized double-blind trials that evaluated safety and tolerability profiles of NAL in patients with chronic non-cancer pain and opioid-induced constipation. Patients had taken opioids for ≥3 months and were subsequently treated for up to 12 weeks with either orally administered 0.2 mg NAL (n=1163) or placebo (n=1165) once a day. For the purposes of their analysis, the researchers focused on tolerability and adverse events such as potential opioid withdrawal.
The mean exposure time was similar in the NAL and placebo groups during the 12-week treatment period (76.6 days and 77.2 days, respectively). A higher percentage of patients reporting adverse drug reactions were in the NAL vs placebo group (20.1% vs 13.6%, respectively; 95% CI, 3.4-9.5). Overall incidence of TEAEs was similar in both groups in all 3 studies. In the overall cohort, TEAEs were primarily associated with the gastrointestinal system and included abdominal pain, diarrhea, and nausea.
Overall, TEAEs were mild to moderate in severity, occurred early in the study, and were relatively short in duration. Abdominal pain, for instance, was reported early and only once during the study, whereas nausea and diarrhea were both reported early and occasionally throughout the study period. The opioid withdrawal incidence was also relatively low in both the treatment (1.0%) and placebo (0.6%) groups.
Webster LR, Magazine HI, Yamada T. Safety of Naldemedine for the treatment of opioid-induced constipation in subjects with chronic non-cancer pain receiving opioid therapy: results of three global phase 3 clinical trials. Presented at: PAINWeek 2018, September 4-8, 2018, Las Vegas, Nevada. Abstract 75.
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