- AstraZeneca headquarters in London.
AstraZeneca announced positive results from two Phase III trials and one safety extension trial in patients with non-cancer related pain and opioid-induced constipation (OIC).
The KODIAC trials evaluated naloxegol for the treatment of OIC, a common side effect of prescription opioids. The trials took place over 12 weeks.
AstraZeneca has headquarters and manufacturing operations in Delaware.
Naloxegol is part of the exclusive worldwide license agreement announced in 2009 between AstraZeneca and Nektar Therapeutics.
“Opioid-induced constipation is a burdensome condition which is often overlooked, inadequately managed and can negatively impact a patient’s quality of life,” said Martin Mackay, president of Research and Development, AstraZeneca. “The top-line results of the pivotal KODIAC studies provide important new information on the safety and efficacy of naloxegol as a potential treatment for opioid-induced constipation and we are looking forward to advancing this programme.”
Naloxegol is currently considered a Schedule II controlled substance by the US Drug Enforcement Administration (DEA) based on structural relatedness to noroxymorphone. AstraZeneca has conducted the studies necessary to evaluate the abuse potential and dependence-producing properties of naloxegol A petition for the decontrol of naloxegol was submitted to the DEA in March 2012 and accepted for review.
Launch in the US will be subject to both FDA and DEA clearances.
