The USFDA approved Movantik
(naloxegol), an oral treatment for opioid-induced constipation in adults
with chronic non-cancer pain.
Opioids are a class of drugs that
are used to treat and manage pain. A common side effect associated with
the use of these drugs are that they reduce the gastrointestinal tract’s
motility, making bowel movements difficult and causing patients to
strain, have hard or lumpy stools or experience a sensation of
incomplete evacuation. Movantik belongs to a class of drugs called
peripherally acting opioid receptor antagonists, which are used to
decrease 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.
Movantik’s
safety and effectiveness were established in two clinical trials of
1,352 participants who had taken opioids for at least four weeks for
non-cancer related pain and had opioid-induced constipation.
Participants were randomly assigned to receive 12.5 mg or 25 mg of
Movantik or placebo (sugar pill) once daily for 12 weeks. The trials
were designed to measure the change in the number of bowel movements per
week from the start of the study.
Results of the first trial
showed that 44 percent of participants receiving 25 mg of Movantik and
41 percent of participants receiving 12.5 mg of Movantik experienced an
increase in bowel movements per week, compared to 29 percent of
participants receiving placebo. The second trial showed similar results.
Common
side effects of Movantik include abdominal pain, diarrhea, headache and
the experience of excessive gas in the stomach or intestinal area
(flatulence).
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