The US Food and Drugs Administration (FDA) have approved AstraZeneca’s Movantik (naloxegol) for opioid-induced constipation in adults.
The oral treatment can be used by sufferers with non-cancer related chronic pain, but the US regulator has asked AZ to carry out a further study to evaluate Movantik’s potential risk for causing cardiovascular adverse effects in patients.
The FDA’s green light for Movantik was based on 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 assigned to receive 12.5mg or 25mg of Movantik or placebo once daily for 12 weeks and the trials were designed to measure the change in number of bowel movements per week compared to the start of the study.
Results of the first trial showed that 44% of participants receiving 25 mg and 41% receiving 12.5 mg of Movantik experienced an increase in bowel movements per week, compared to 29% of participants receiving placebo. The second trial showed similar results.
Dr Briggs Morrison, executive vice president of global medicines development and chief medical officer at AstraZeneca, said: “The FDA approval of Movantik provides a new treatment option for adult patients with chronic non-cancer pain suffering from opioid-induced constipation, a common side effect of opioid therapy. We are pleased to provide physicians and their patients with a once-daily oral treatment supported by a robust clinical programme.”
Although a common side effect of taking opioids can be struggling to make bowel movements, Movantik belongs to a class of drugs called peripherally acting opioid receptor antagonists that are used to decrease the typical constipating effect of opioids.
Julie Beitz, director of the office of drug evaluation III in FDA’s centre for drug evaluation, said: “Supportive care products such as Movantik can lessen the constipating side effects of opioids.”
Common side effects of Movantik include abdominal pains, diarrhoea, headaches and flatulence.