AstraZeneca has received approval from the US Food and Drug Administration (FDA) for its Movantik (naloxegol) tablets C-II to treat opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
Naloxegol is said to be the first FDA approved once-daily peripherally acting mu-opioid receptor antagonist (PAMORA) to treat OIC.
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.
"We are pleased to provide physicians and their patients with a once-daily oral treatment supported by a robust clinical programme."
Approval was based on results from the Kodiac clinical programme, which comprised four studies, Kodiac-4, 5, 7 and 8.
Kodiac-4 and 5 are placebo controlled, double-blind and 12 week studies, which evaluated safety and efficacy, while Kodiac-7 was a 12 week safety extension to Kodiac-4, and Kodiac-8 was a 52-week open label and long-term safety study.
The company plans to launch the product in the first half of 2015.
At present, movantik is a schedule II controlled substance, as it is structurally similar to noroxymorphone.
In March 2012, the company submitted an application for descheduling of the product to the US Drug Enforcement Administration (DEA). It was accepted by DEA for review to address the descheduling request.
Movantik, which is part of the exclusive worldwide licence agreement between AstraZeneca and Nektar Therapeutics, has been developed by using Nektar’s oral small molecule polymer conjugate technology.