AstraZeneca-supported OIC trials achieve primary objective

Pharmaceutical Company Product News

AstraZeneca-supported phase III trials of Naloxegol, an oral, peripherally acting opioid-induced constipation (OIC) medicine, have shown the drug to be safe and effective.

The results of the KODIAC-04 and KODIAC-05 trials displayed a primary outcome in which patients had more than three spontaneous bowel movements (SBMs) per week, with an increase of more than one SBM per week over baseline in more than three-quarters of the 12 randomised weeks.

“AstraZeneca-supported trials have shown Naloxegol to be safe and effective in the treatment of OIC.“

Dr William Chey, professor of medicine at the University of Michigan Health System in Ann Arbor, explained the study objectives were to evaluate the safety and efficacy of naloxegol in two doses against placebo in patients taking opioids for noncancer pain.

OIC can develop in up to 60 percent of individuals taking opioids.

Dr Chey added: "We tend to focus on stool frequency, but like constipation in general, OIC is associated with alterations in a variety of other symptoms, including straining, hard stools and a sense of incomplete evacuation."

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