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Naloxegol (Movantik) Approved for Opioid-Related Constipation

Study evaluates potential for cardiovascular events

The FDA has given “thumbs up” to naloxegol (Movantik, AstraZeneca), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

Opioids commonly reduce the gastrointestinal tract’s motility, making bowel movements difficult and causing patients to strain, to have hard or lumpy stools, or to experience a sensation of incomplete evacuation. Naloxegol belongs to a class of drugs called peripherally acting opioid receptor antagonists, which are used to reduce the constipating effects of opioids.

The safety and effectiveness of naloxegol were established in two clinical trials involving a total of 1,352 participants who had been treated with opioids for at least 4 weeks for non–cancer-related pain and who had opioid-induced constipation. The participants were randomly assigned to receive 12.5 mg or 25 mg of naloxegol or placebo once daily for 12 weeks. The studies were designed to measure the change in the number of bowel movements per week from the start of treatment.

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

Common side effects of naloxegol include abdominal pain, diarrhea, headache, and flatulence.

The FDA is requiring a post-marketing study to further evaluate the potential risk of cardiovascular adverse events in patients treated with naloxegol. In June, the FDA held a public meeting to discuss what studies might be required to assess the cardiac safety of peripherally acting opioid receptor antagonists, including naloxegol, intended to treat opioid-induced constipation.

Source: FDA; September 16, 2014.

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