Sunday, November 11, 2012

AstraZeneca reports Postiive topline Phase results on Naloxegol in patients with OpioId Induced constipation

AstraZeneca reported positive Phase III data from KODIAC trials evaluating the  the safety and efficacy of naloxegol, an oral peripherally-acting, mu-opioid receptor antagonist for the treatment of Opioid Induced Constipation in patients with non-cancer related pain.


KODIAC-04 and 05 trial design and Endpoints   
KODIAC-04 and -05 are both multicenter, randomized, double-blind, placebo-controlled pivotal trials of 12 weeks duration evaluating 12.5 mg and 25 mg naloxegol administered once-daily. The primary endpoint in both trials was percentage of OIC responders versus placebo over 12 weeks of treatment 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

KODIAC-4 Trial Results 
Efficacy
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 endpoint. P-values were 0.015 and 0.001 respectively.

KODIAC-5 Trial Results
Efficacy
In KODIAC-05, the 25 mg dose demonstrated a statistically significant result for the primary endpoint but the 12.5 mg dose did not. P-values were 0.202 for 12.5 mg and 0.021 for 25 mg.

Safety
There were 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. The most common adverse events (AEs) in the naloxegol treatment arms in both trials were abdominal pain, diarrhea and nausea.  In KODIAC-07, (the safety extension of KODIAC-04) the occurrence of AEs and SAEs was lower than in KODIAC-04 and -05. Among non serious adverse events, arthralgia was the most common and was reported only in patients in the naloxegol 25 mg arm.
 


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