AstraZeneca Receives FDA Approval for New Molecular Entity NaloxegolBy
AstraZeneca has received US Food and Drug Administration (FDA) approval for Movantik (naloxegol) tablets C-II as an once-daily, oral treatment for opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.
Movantik is part of the exclusive worldwide licence agreement, formed in 2009, between AstraZeneca and Nektar Therapeutics. Movantik was developed using Nektar's oral small-molecule polymer conjugate technology. It is a peripherally-acting mu-opioid receptor antagonist. Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract, which can result in patients suffering from OIC.
The drug is expected to be available to patients in the first half of 2015. Movantik is currently a Schedule II controlled substance because it is structurally related to noroxymorphone. During the review of the new drug application, the FDA evaluated the abuse potential of Movantik, and the approved labelling indicates that Movantik has no risk of abuse or dependency. AstraZeneca submitted a petition for the descheduling of Movantik to the US Drug Enforcement Administration (DEA) in March 2012, which was accepted for review and will be considered by the DEA as part of the process for addressing the descheduling request.
Naloxegol is also under regulatory review by the European Medicines Agency.