FDA News

FDA approves Movantik for opioid-induced constipation

The FDA today approved naloxegol, an oral therapeutic indicated for opioid-induced constipation in adults with chronic noncancer pain, according to an FDA news release.

Naloxegol (Movantik, AstraZeneca) is a peripherally acting opioid receptor antagonist, a class of drugs used to mitigate the reduction of gastrointestinal motility commonly associated with opioid use.

“Supportive care products such as Movantik can lessen the constipating side effects of opioids,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the release.

The approval comes in response to results from two clinical trials of 1,352 patients that indicated naloxegol safely and effectively reduced opioid-induced constipation. In one of the trials, 44% of patients assigned 25 mg naloxegol and 41% of those assigned 12.5 mg naloxegol once daily for 12 weeks experienced increased bowel movements compared with 29% of controls assigned placebo, the release said. The most common side effects were abdominal pain, diarrhea, headache and flatulence.

The FDA has required a postmarketing study to further assess the risk for cardiovascular adverse events and held a public meeting in June about studies to evaluate that risk associated with this class of drugs.

The FDA today approved naloxegol, an oral therapeutic indicated for opioid-induced constipation in adults with chronic noncancer pain, according to an FDA news release.

Naloxegol (Movantik, AstraZeneca) is a peripherally acting opioid receptor antagonist, a class of drugs used to mitigate the reduction of gastrointestinal motility commonly associated with opioid use.

“Supportive care products such as Movantik can lessen the constipating side effects of opioids,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the release.

The approval comes in response to results from two clinical trials of 1,352 patients that indicated naloxegol safely and effectively reduced opioid-induced constipation. In one of the trials, 44% of patients assigned 25 mg naloxegol and 41% of those assigned 12.5 mg naloxegol once daily for 12 weeks experienced increased bowel movements compared with 29% of controls assigned placebo, the release said. The most common side effects were abdominal pain, diarrhea, headache and flatulence.

The FDA has required a postmarketing study to further assess the risk for cardiovascular adverse events and held a public meeting in June about studies to evaluate that risk associated with this class of drugs.