Nektar: FDA Accepts New Drug Application For Naloxegol - Quick Facts

(RTTNews) - Nektar Therapeutics (NKTR) reported that its partner AstraZeneca (AZN.L, AZN) announced the U.S. FDA has accepted the New Drug Application (NDA) for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist, which has been studied in opioid-induced constipation in adult patients with chronic non-cancer pain, the most common side effect caused by chronic administration of prescription opioid pain medicines.

The NDA filing was based on the data from the core Phase III KODIAC programme, which is comprised of four clinical trials designed to investigate the safety and efficacy of naloxegol for the treatment of opioid-induced constipation.

Naloxegol is part of the exclusive worldwide license agreement announced on 21 September 2009, between AstraZeneca and Nektar Therapeutics. Under the terms of the amended license agreement, AstraZeneca will make a $70 million milestone payment to Nektar within five business days of acceptance of the NDA by the FDA.