ARTICLE | Clinical News

Movantik naloxegol regulatory update

September 22, 2014 7:00 AM UTC

FDA approved an NDA from AstraZeneca for once-daily Movantik naloxegol to treat opioid-induced constipation (OIC) in adults with chronic non-cancer pain. AZ plans to launch the pegylated form of the peripheral mu opioid receptor ( OPRM1; MOR) antagonist naloxol next half. As part of the approval, FDA is requiring a postmarketing, observational epidemiologic study; the primary endpoint will be a composite of major adverse cardiovascular events (MACE).

The approval triggered a $35 million milestone payment to partner Nektar under an amended 2009 deal granting the pharma exclusive, worldwide rights to Nektar's naloxegol, which was developed using Nektar's oral small molecule polymer conjugate technology. Nektar also is eligible for a $100 million milestone payment upon U.S. launch, a $40 million payment upon EU launch, sales milestones totaling $375 million and royalties. The product is under review in Europe to treat OIC in patients with chronic non-cancer pain, with a decision expected by year end. ...