AstraZeneca’s Movantik Clears FDA; Launch On Hold Pending DEA Action
This article was originally published in The Pink Sheet Daily
Naloxegol is currently a Schedule II controlled substance due to its structural similarity to another compound; AstraZeneca seeks descheduling of the constipation drug, which labeling states poses no risk of abuse or dependency.
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The latest drug development news and highlights from our US FDA Performance Tracker.
FDA approval of the first oral form of Valeant’s mu-opioid receptor antagonist Relistor will pit the franchise against Movantik for the treatment of patients with opioid-induced constipation with non-cancer pain.
Janssen moves into a new generation of anticoagulation with X01 buyout. Lilly obtains Phase II-ready autoimmune candidate from South Korea’s Hanmi, which partnered a cancer compound with Spectrum just a week earlier, while AstraZeneca finds a commercialization partner for Movantik in Japan’s Daiichi Sankyo.