Naldemedine for the Treatment of Opioid-Induced Constipation in Adults with Chronic Noncancer Pain

Abstract

This review aims to summarize the efficacy data for naldemedine, a member of the novel peripherally acting μ-opioid receptor antagonists (PAMORAs), which gained US FDA approval for the treatment of opioid-induced constipation in adults with chronic noncancer pain-related syndromes in 2017. In Phase III trials, patients receiving naldemedine were significantly more likely to meet the primary end point ≥3 spontaneous bowel movements/week and an increase of ≥1 spontaneous bowel movement/week from baseline for at least 9/12 weeks compared to placebo (p < 0.0001). The most frequent adverse events were abdominal pain (8%) and diarrhea (7%). Based on available data, naldemedine appears to be an effective and safe first-line therapy for the treatment of opioid-induced constipation in adults with chronic noncancer pain.

Keywords::

• constipation
• opioids
• pain management

Financial & competing interests disclosure

DM Brenner reports roles as a consultant, advisor, and/or speaker for the following corporations: Allergan, Ironwood, Salix, Takeda, Alnylam, AlphaSigma, Bayer, Arena Pharmaceuticals and the GI Health Foundation. Research is supported by an unrestricted gift from the Irene D Pritzker Foundation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

DM Brenner reports roles as a consultant, advisor, and/or speaker for the following corporations: Allergan, Ironwood, Salix, Takeda, Alnylam, AlphaSigma, Bayer, Arena Pharmaceuticals and the GI Health Foundation. Research is supported by an unrestricted gift from the Irene D Pritzker Foundation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.