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news.The US Food and Drug Administration (FDA) has approved AstraZeneca’s Movantik tablets C-II as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.
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The approval was based on data obtained from the KODIAC clinical programme, which involved four studies, namely KODIAC-4, -5, -7 and -8.
While KODIAC-4 and -5 were both placebo controlled, double-blind, 12 week studies assessing safety and efficacy, the KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8 was a 52 week open label, long-term safety study.
AstraZeneca Global Medicines Development executive vice-president and chief medical officer Dr Briggs Morrison 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."
Also called naloxegol, Movantik is currently a schedule II controlled substance, and is expected to be made available to patients during the first half of 2015.
During the review of the New Drug Application, the drug proved to FDA that it has no risk of abuse or dependency.
Naloxegol is also under regulatory review by the European Medicines Agency (EMA).
The drug was developed using Nektar’s oral small molecule polymer conjugate technology as part of the exclusive worldwide licence agreement signed between AstraZeneca and Nektar Therapeutics in September 2009.