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AstraZeneca Reveals Safety Analyses Data For Movantik

AstraZeneca Plc (AZN) on Saturday revealed Movantik - naloxegol - had a similar incidence of adverse events among elderly patients as compared to placebo or usual care, in a presentation at the Digestive Disease Week 2015 in Washington, D.C.

The study evaluated the effects of daily oral administration of Movantik 12.5 mg or 25 mg versus placebo among outpatients 65 years and older with opioid-induced constipation and chronic non-cancer pain. The results came after further analysis of the Phase III KODIAC-04, KODIAC-05 and KODIAC-08 studies.

The incidence of adverse events reported among patients taking Movantik was similar to those taking placebo or usual care. Safety results among this subset were generally consistent with those seen in the overall patient populations from phase 3 studies.

The most common adverse reactions with Movantik as compared to placebo in clinical trials were: abdominal pain (21% vs. 7%), diarrhea (9% vs. 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs. 3%), and hyperhidrosis (3% vs. <1%)

Movantik is a once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain. When administered at recommended dose levels, Movantik decreases the constipating effect of opioids by blocking opioids from binding to mu-receptors in the bowel. And because of its design, at recommended doses, the CNS penetration of naloxegol is expected to be negligible, limiting potential interference with centrally mediated opioid analgesia.

AZN closed Friday at $69.29, down $0.81 or 1.16%, on a volume of about 1.27 million shares on the New York Stock Exchange.

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