The objective of the formal pharmacokinetic (PK) study was to support identification of an alternative dosing formulation of Zenvia to deliver similar efficacy as observed in the first Phase III clinical study in diabetic peripheral neuropathic pain but with an improved safety and tolerability profile.
The study achieved its goal of identifying a new Zenvia dosing regimen that provides a similar pharmacokinetic profile of the dextromethorphan component, an improved adverse event profile and a lower overall exposure to quinidine compared to the previously studied doses.
The formal PK study is a single center, randomized, double-blind, placebo-controlled, parallel-group, multiple dose pharmacokinetic evaluation of various dose combinations and regimens of dextromethorphan and quinidine. Safety was determined by evaluating vital signs, laboratory parameters, ECGs, physical examination, and by recording adverse events during the treatment period.
Randall Kaye, chief medical officer of Avanir, said: “We have now identified a dosing regimen which, based on its observed PK parameters, we expect to demonstrate comparable efficacy with improved safety and tolerability relative to the regimens previously demonstrating efficacy in diabetic peripheral neuropathic pain.”