The US Food and Drug Administration (FDA) has accepted AstraZeneca's new drug application (NDA) for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA).
The drug 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 submission of the NDA was based on data from the core Phase III KODIAC program, which included four clinical trials designed to evaluate the safety and efficacy of naloxegol for the treatment of OIC.
In the 12-week, multicenter, randomized, double blind, placebo-controlled KODIAC-04 and KODIAC-05 trials, patients were assessed with 12.5mg and 25mg doses of naloxegol once-daily.
The company said that KODIAC-07 is a 12-week safety extension of KODIAC-04, while KODIAC-08 was an open-label controlled, randomized, 52-week, long-term safety trial.
Naloxegol is part of a worldwide license agreement announced in 2009, between AstraZeneca and Nektar Therapeutics, under which AstraZeneca will make a $70m milestone payment to Nektar within five business days of acceptance of the NDA by the FDA.
The drug, which was developed using Nektar's oral small molecule polymer conjugate technology, is claimed to have the potential to be the first once-daily oral PAMORA for patients with OIC in the US.
It is a once-daily tablet designed to block the binding of opioids to the opioid receptors in the gastrointestinal (GI) tract without impacting the opioid receptors in the brain.
