AstraZeneca has announced that the Drug Enforcement Administration (DEA) has removed Movantik (naloxegol) from the schedules of the Controlled Substances Act (CSA) effective immediately. Movantik is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
Movantik was previously approved in September 2014 as a Schedule CII controlled substance because it is structurally related to noroxymorphone. After a review of the available data that included scientific and medical evaluation, plus a recommendation from the Department of Health and Human Services (HHS) to decontrol naloxegol, the DEA published in the Federal Register a notice of proposed rulemaking (NPRM) on the removal of naloxegol and its salts from the schedules of the CSA. In the absence of comparable effective therapeutic treatment for OIC with similar or less adverse events than naloxegol, the descheduling is effective immediately.
Movantik is a peripherally acting mu-opioid receptor antagonist (PAMORA). It is designed to block the binding of opioids to the opioid receptors in the gastrointestinal tract without impacting the opioid receptors in the brain. Movantik was developed using Nektar Therapeutics’ oral small molecule polymer conjugate technology. It is expected to launch in the first half of 2015.
For more information visit Movantik.com.