Moventig, positive CHMP opinion in the European Union for the treatment of adults with opioid-induced constipation
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).
Opioid-induced constipation 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 opioid-induced constipation.
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.
In phase III clinical studies, Moventig was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors in tissues such as the gastrointestinal tract.
The KODIAC clinical programme was comprised of four studies: KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were identically designed, placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8 was a 52 week long-term safety study. ( Xagena )
Source: AstraZeneca, 2014