AstraZeneca’s naloxegol accepted for European review

AstraZeneca has announced that the European Medicines Agency has accepted its marketing authorisation application for naloxegol, its new constipation therapy.

The investigational peripherally-acting mu-opioid receptor antagonist has been specifically designed for the treatment of opioid-induced constipation for adult patients over the age of 18, including those who have experienced an inadequate response to laxatives.

Developed in partnership between AstraZeneca and Nektar Therapeutics, the product was created using Nektar's oral small molecule polymer conjugate technology and has the potential to become the first therapy of its kind for this condition.

Data from the core phase III Kodiac programme has demonstrated the safety and efficacy of the new drug across four separate clinical trials.

The acceptance of the marketing authorisation application also triggers a $25 million (15.56 million pounds) milestone payment from AstraZeneca to Nektar.

This comes in the same week that AstraZeneca also received a recommendation from Europe's Committee for Medicinal Products for Human Use for approval of its new flu vaccine product Fluenz Tetra.