LONDON (dpa-AFX) - AstraZeneca PLC (AZN) Tuesday said the Phase III study of the investigational drug naloxegol, 25 mg, met its primary and secondary endpoints and showed a safety profile. Naloxegol is a peripherally-acting mu-opioid receptor antagonist, which has been specifically designed for the treatment of opioid-induced constipation, a common and often debilitating side effect of prescription opioid pain medicines, said the company.
The Phase III studies, KODIAC-04 and -05, evaluated 12.5 mg and 25 mg doses of naloxegol, administered once-daily. The primary endpoint in both trials was percentage of OIC responders, versus placebo, over 12 weeks of treatment. The secondary endpoints included the 12-week response rate in a laxative inadequate response population, the median time to first spontaneous bowel movement and the number of days per-week with at least one bowel movement.
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