Naldemedine in Japanese patients with opioid-induced constipation and chronic noncancer pain: open-label Phase III studies.

ABSTRACT:

Introduction

Naldemedine is a peripherally-acting µ-opioid-receptor antagonist, approved in Japan for opioid-induced constipation (OIC). In two open-label, single-arm, Phase III studies, we evaluated the safety and efficacy of naldemedine in Japanese patients with OIC receiving regular-use opioids (COMPOSE-6) or prolonged-release oxycodone (COMPOSE-7) for chronic noncancer pain.

Methods

Eligible Japanese adults with OIC and chronic noncancer pain received once-daily oral naldemedine 0.2 mg for 48 weeks, irrespective of food intake. Primary end points included measures of treatment-emergent adverse events (TEAEs), pain intensity, and opioid withdrawal. Secondary efficacy end points were evaluated at treatment week 2. Patient Assessment of Constipation Symptoms (PAC-SYM) and Q

SUBMITTER: Saito Y 

PROVIDER: S-EPMC6307491 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature