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FDA Clears Movantik to Treat Opioid-Induced Constipation

First Posted: Sep 20, 2014 07:54 AM EDT

The U.S. FDA Panel gave an approval to Movantik, an oral treatment intended to treat opioid-induced constipation and to manage pain.

The U.S. Food and Drug Administration announced that it had approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

Opiods are the class of drugs that are generally used to treat and manage pain. The most common side effect linked with the use of these drugs is that they lower the gastrointestinal tract's motility, making bowel movements difficult causing strain, hard or lumpy stools. The newly-approved oral treatment belongs to the class of drugs called peripherally acting opioid receptor antagonists, which is intended to lower the constipating effects of opioids.

"Supportive care products such as Movantik can lessen the constipating side effects of opioids," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research.

The safety and effectiveness of the Movantik was tested in two clinical trials that included 1,352 participants that had taken opioid for a minimum of four weeks for non-cancer related pain and had opioid-induced constipation. As a part of the study, the participants were randomly given either 12.5 mg or 25 mg of Movantik or placebo - a sugar pill - once daily for 12 weeks. These trails were done to measure the change in the number of bowel movement per week right from the start of the study.

In the first trial, the researchers noticed that 44 percent of the participants who got 25 mg of Movantik and 42 percent of them who received 12.5 mg of Movantik had an increase in bowel movement per week, when compared to 29 percent of the participants receiving placebo. They noticed similar results in the second trail.

The common side effects noticed included abdominal pain, diarrhea, headache and excessive gas in the stomach or intestinal area.

The drug is marketed by AstraZeneca Pharmaceuticals.

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