FDA Approves New Rx for Constipation Caused by Opioids

Movantik gets FDA approval to treat opioid induced constipation in adults with chronic pain unrelated to cancer

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Opioid painkillers bring needed relief to many patients, but they also come with a host of side effects — one of the most common being constipation. The US Food and Drug Administration (FDA) just approved a new medication to ease this uncomfortable side effect.

The FDA gave its thumbs-up to Movantik (naloxegol) — an oral treatment for constipation caused by opioids in adults with chronic, non-cancer pain.

"Tell your pharmacist if you are feeling constipated after starting opioid treatment."

Opioids are used to treat and manage pain. They have received a lot of media attention lately because of their highly addictive qualities and association with overdose deaths. But opioids are also associated with less sinister health issues, such as constipation.

Constipation is a condition in which bowel movements become difficult. People with constipation strain to have a bowel movement, have hard or lumpy stools or have the feeling that they did not completely evacuate.

Movantik is part of a class of medications known as peripherally acting opioid receptor antagonists. These are used to reduce the constipating effects of opioids.

"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 at the FDA, in a press release.

Researchers tested Movantik in two clinical trials of more than 1,300 people who had taken opioids for at least four weeks and who had constipation. None of these patients took opioids to treat pain from cancer.

The patients took either 12.5 or 25 milligrams of Movantik or placebo (fake pills) once a day for 12 weeks.

The researchers found that 44 percent of those taking 25 milligrams had more bowel movements per week than at the start of the study. A total of 41 percent of those taking 12.5 milligrams of Movantik had an increase in their weekly bowel movements.

Only 29 percent of the placebo patients had an increase in weekly bowel movements.

The FDA reports that common side effects of Movantik include stomach pain, diarrhea, headache and excessive gas.

The FDA plans further study of the possible risk of cardiovascular issues in patients taking Movantik.

AstraZeneca Pharmaceuticals will distribute Movantik.

Review Date: 
September 16, 2014
Last Updated:
September 16, 2014