FDA Approves AstraZeneca's Movantik

September 16, 2014
Pharmaceutical Technology Editors

AstraZeneca's Movantik was approved by FDA in the treatment of opioid-induced constipation.

On Sept. 16, 2014, FDA approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain. Movantik belongs to a class of drugs called peripherally acting opioid receptor antagonists, which are used to decrease the constipating effects of opioids.

Movantik’s safety and effectiveness were established in two clinical trials of 1352 participants who had taken opioids for at least four weeks for non-cancer related pain and had opioid-induced constipation. Participants were randomly assigned to receive 12.5 mg or 25 mg of Movantik or placebo once daily for 12 weeks. The trials were designed to measure the change in the number of bowel movements per week from the start of the study.

Results of the first trial showed that 44% of participants receiving 25 mg of Movantik and 41% of participants receiving 12.5 mg of Movantik experienced an increase in bowel movements per week, compared to 29% of participants receiving placebo. The second trial showed similar results.

Source: FDA