Drugs giant AstraZeneca has announced a clutch of positive test results relating to its naloxegol product, a treatment for opioid-induced constipation (OIC).
The results come from two Phase III trials and one safety extension trial in patients with non-cancer related pain and OIC.
The Phase III KODIAC trials evaluated the safety and efficacy of naloxegol over a 12 week period. The primary end-point in the KODIAC-04 and KODIAC-05 trials was the percentage of OIC responders versus the placebo, where a responder was defined as having at least three spontaneous bowel movements (SBM) per week, with at least one SBM per week increase over baseline, for at least nine out of 12 weeks, and at least three out of the last four weeks.
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Under the design of both trials, statistical significance for the primary end-point would be achieved if at least one of the two naloxegol doses had a p-value less than 0.025 compared with placebo; the p-value measures consistency between the results from the trial and the "blind luck" explanation for those results.
Analysis of the data indicates that in KODIAC-04 both naloxegol doses (12.5 mg and 25 mg) demonstrated statistically significant results for the primary end-point, Astra revealed. P-values were 0.015 and 0.001 respectively.
The analyses also showed no clinically relevant imbalances in serious adverse events (SAEs), including externally adjudicated major cardiovascular events, across the three treatment arms in KODIAC-04, -05 and -07.
Naloxegol is part of the exclusive worldwide licence agreement announced on 21 September 2009 between AstraZeneca and US drugs developer Nektar Therapeutics. Naloxegol was developed using Nektar's oral small molecule polymer conjugate technology.
"The top-line results of the pivotal KODIAC studies provide important new information on the safety and efficacy of naloxegol as a potential treatment for opioid-induced constipation and we are looking forward to advancing this programme," said Martin Mackay, President of Research and Development at AstraZeneca.
Worldwide, some 40-50% (28m to 35m) of patients taking opioids for long-term pain develop constipation. About 40-50% (11m - 18m) of those OIC sufferers achieve the desired treatment outcomes with current options that include over-the-counter and prescription laxative.
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