New Drug Application for naloxegol accepted by United States Food and Drug Administration

AstraZeneca today announced that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA), which has been studied in opioid-induced constipation (OIC) 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 comprehensive 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 OIC. Two pivotal Phase III studies, KODIAC-04 (n=652) and KODIAC-05 (n=700), both 12-week, multicentre, randomised, double blind, placebo-controlled pivotal trials evaluated 12.5 mg and 25 mg doses of naloxegol, administered once-daily. KODIAC-07, a 12-week safety extension of KODIAC-04, and KODIAC-08 (n= 534) was an open-label controlled, randomised, 52-week, long-term safety trial.

Naloxegol has the potential to be the first once-daily oral PAMORA for patients with OIC in the United States. Naloxegol was developed using Nektar’s oral small molecule polymer conjugate technology.

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.