CHMP Recommends AstraZeneca's Moventig For Opioid-Induced Constipation

AstraZeneca reported that it has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Moventig as treatment for opioid-induced constipation (OIC) in adults who responded inadequately to laxatives.

Moventig (naloxegol) is an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA). The drug is designed to block the binding of opioids to its receptors gastrointestinal tract tissues. Moventig was developed by Nektar Therapeutics using its oral small molecule polymer conjugate technology and was licensed by AstraZeneca in September 2009 as part of an exclusive global license agreement. Reuters reports that Nektar is eligible to receive up to $235 million in payment once the drug meets regulatory milestones, as well as up to $375 million based on sales milestones.

Opioid-induced constipation is a side effect of opioid pain relieving drugs. Opioids bind to mu-receptors in the patients’ central nervous system to relieve pain and, with the same mechanism of action, bind to mu-receptors in the gastrointestinal tract, leading to constipation.

The recommendation from the European committee was based on a review of positive data from the company’s KODIAC clinical program made up of four studies that evaluated Moventig’s safety and efficacy.

The positive opinion from CHMP comes after the recent approval of Movantik earlier this month by the U.S. Food and Drug Administration (FDA). The U.S. regulatory agency approved Movantik as treatment for OIC in adults suffering from chronic non-cancer pain. However, the FDA required the company to conduct a post-marketing study to further assess the drug’s potential risk to induce cardiovascular adverse events in patients who use Movantik.

In a long-term safety trial conducted for the trial last year involving 534 patients who took the drug, AstraZeneca reported that naloxegol’s side effects also included diarrhea, headache, nausea, and abdominal pain.