FDA OKs Drug for Non-Cancer Opioid Constipation
Movantik (naloxegol), taken once daily, blocks opioid receptors in the gut but does not cross the blood-brain barrier to affect opioid analgesia. It is expected to be available sometime in the first half of 2015.
The US Food and Drug Administration has approved an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.
Movantik (naloxegol), distribued by AstraZeneca, is a peripherally acting opioid receptor antagonist that blocks opioid receptors in the gut without crossing the blood-brain barrier to interfere with analgesia.
Its safety and effectiveness were established in the two placebo-controlled KODIAC trials involving 1,352 participants, published in the New England Journal of Medicine last June.
Common side effects of the drug, which is taken once daily, include abdominal pain, diarrhea, headache, and flatulence.
According to AstraZeneca, Movantik is expected to be available to patients in the first half of 2015.
Although it is labeled as having no risk of abuse or dependincy, because naloxegol is related structurally to noroxymorphone the drug is currently a Schedule III controlled substance. AstraZeneca has submitted a request to de-schedule it.
