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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
FDA approves Movantik for opioid-induced constipation

The U.S. Food and Drug Administration 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).

The FDA is requiring a postmarketing study to further evaluate the potential risk of cardiovascular adverse events in patients taking Movantik. In June, the FDA held a public meeting to discuss what studies might be required to assess the cardiac safety of peripherally acting opioid receptor antagonists, including Movantik, intended to treat opioid-induced constipation.

Movantik is distributed by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.