CHMP recommends Moventig for the treatment of Opioid-induced Constipation - AstraZeneca
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Moventig (naloxegol), an investigational, peripherally-acting mu-opioid receptor antagonist (PAMORA), for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
OIC is a condition caused by prescription opioid pain medicines. Opioids work by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract, which can result in patients suffering from OIC. The positive opinion was reached after a review of comprehensive data from the KODIAC clinical programme comprised of four studies assessing the safety and efficacy of Moventig.
FDA approval for Moventik was given on 16 September 2014.