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.

"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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.