Movantik Launch Is Delayed as DEA Considers Descheduling Request
AstraZeneca and Nektar Therapeutics say they hope to market their newly approved opioid-induced constipation drug Movantik in early 2015, but the launch date remains uncertain as the Drug Enforcement Administration considers a request to deschedule the product.
The FDA approved Movantik (naloxegol) as the first mu receptor-targeting opioid constipation drug for adults with chronic pain that is not caused by cancer. The DEA, however, must still act on the drugmakers’ March 2012 request to remove its designation as a schedule II controlled substance. Schedule II drugs are those that have a high risk of abuse and dependence.
The drugmakers say the FDA specifically evaluated the abuse potential of Movantik, and the approved labeling indicates it has “no risk of abuse or dependency.” The agency’s approval was based on results of four safety and efficacy studies that showed that patients taking Movantik had quick and long-lasting improvement without compromising their pain management, Nektar spokeswoman Nadia Hasan said.
AstraZeneca has committed to conducting a postmarket observational cardiovascular safety trial, in line with an FDA advisory panel recommendation in June. The same panel recommended such trials earlier this year after a study of Cubist’s Entereg (avilmopan) showed a higher incidence of heart attacks among patients on the study drug.
The drug, which AstraZeneca licensed from Nektar in 2009, is the third of its kind to be approved in the last six months. In April, Sucampo saw Amitiza (lubiprostone) approved for OIC, followed in July by Salix Pharmaceuticals’ Relistor (methylnatrexone bromide).
Movantik is currently also awaiting approval in the European Union. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.