AstraZeneca has announced that the United States Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for naloxegol.
The investigational peripherally-acting mu-opioid receptor antagonist (PAMORA) 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, states AstraZeneca. The NDA filing was based on 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 and KODIAC-05, 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 was an open-label controlled, randomised, 52-week, long-term safety trial.
Naloxegol is part of the 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.