FDA clarifies Movantik label

FDA updated the label for Movantik naloxegol to clarify that the compound is approved to treat opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Movantik was initially approved in 2014 to treat OIC with chronic non-cancer pain.

AstraZeneca plc (LSE:AZN; NYSE:AZN) has exclusive, worldwide rights to Movantik from Nektar Therapeutics (NASDAQ:NKTR) under a 2009 deal. In 2015, AstraZeneca and Daiichi Sankyo Co. Ltd. (Tokyo:4568) partnered to co-commercialize Movantik in the U.S. AstraZeneca granted the ProStrakan Group plc subsidiary of Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) exclusive rights to develop and commercialize the product as Moventig in the EU, Iceland, Norway, Switzerland and Liechtenstein (see BioCentury, Sept. 28, 2009; April 6, 2015; & March 14, 2016)...