AstraZeneca again reported promising results from a lengthy safety trial of naloxegol on patients patients with non-cancer related pain and suffering from constipation from using opiods such as morphine.
In the trial, a total of 534 patients received naloxegol once daily for up to 52 weeks
“These high-level results are similar to the safety results seen in the Phase III studies previously reported and provide further confidence in the data we’ve seen to date for naloxegol,” said Briggs Morrison, M.D., executive vice president, global medicines Development, AstraZeneca. “We have now completed our core Phase III program and we are pleased to advance naloxegol toward a regulatory submission later this year.”
A New Drug Application filing in the US and a Marketing Authorization Application (MAA) filing in the European Union are planned for the third quarter of 2013, pending AstraZeneca’s final preparation of the registration package and a meeting with the FDA.
Naloxegol is part of the exclusive worldwide license agreement announced on 21 September 2009, between AstraZeneca and Nektar Therapeutics. Nektar could earn up to $600 million from the drug if it achieves certain milestones. For its part, AstraZeneca is in need of a top selling drug as mainstays go off patents.
Naloxegol is currently considered a Schedule II controlled substance by the US Drug Enforcement Administration based on structural relatedness to noroxymorphone. AstraZeneca has conducted the studies necessary to evaluate the abuse potential and dependence-producing properties of naloxegol in support of obtaining decontrol.
A petition for the decontrol of naloxegol was submitted to the DEA in March 2012 and was accepted for review. Launch in the US will be subject to both FDA approval and DEA schedule determination.