AstraZeneca's opioid constipation drug wins US approval
- Movantik (naloxegol) is an oral, once-daily treatment that the FDA has approved to treat opioid-induced constipation in adults with non-cancer pain.
- Movantik was licensed from Nektar Therapeutics. Its mode of action is peripherally-acting mu-opioid receptor antagonism.
- Overall, 44% of patients treated with a 25-mg dose of Movanik had increased frequency of bowel movements.
In phase III trials, patients who took 25 mg doses of Movantik had a 44% increase in bowel movements, compared with 29% for placebo. This difference was enough to gain FDA approval; however, the agency has requested a postmarketing study to evaluate the potential risk of cardiovascular adverse events related to the drug.
Movantik is also categorized as a class II controlled substance because of its structural similarity to noroxymorphone. The labeling notes that there is no risk of habituation and AstraZeneca has requested that Movantik be de-scheduled. Launch is expected in the first half of 2015.