FDA Approves AstraZeneca's Movantik for Opioid-Induced Constipation

The FDA today approved AstraZeneca’s naloxegol (Movantik) treatment for opioid-induced constipation (OIC) in adults with chronic noncancer pain (CNCP).

According to the FDA, Movantik belongs to a class of drugs called peripherally acting mu-opioid receptor antagonists (PAMORA) that are administered to decrease OIC, a common side effect associated with opioid use.

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

The safety and effectiveness of the OIC drug were established in a pair of clinical trials that examined 1,352 CNCP patients who experienced OIC while taking opioids for at least 4 weeks. In the trials, the participants were randomly assigned to receive 12.5 mg or 25 mg of Movantik or placebo once daily for 12 weeks.

Both trials similarly showed 44% of those who received the 25 mg dose and 41% of those who received the 12.5 mg dose experienced an increase in bowel movements per week, compared to 29% of those who received placebo. The common side effects of Movantik include abdominal pain, diarrhea, headache and the experience of excessive gas in the stomach or intestinal area (flatulence), the FDA said.

To further evaluate the potential risk of adverse cardiovascular events among patients taking Movantik, the FDA is requiring a postmarketing study on the drug developed by Nektar Therapeutics and distributed by AstraZeneca.

In June 2014, the FDA held a meeting to discuss which studies might be required to assess the cardiac safety of peripherally acting mu-opioid receptor antagonists, including Movantik, that are intended to treat OIC.