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Applicant’s eszopiclone response: They presented a summary table of differences, that they attribute to (S)-zopiclone versus racemic zopiclone: shorter Tmax, lack of dose-dependency of Tmax , faster sleep onset, relative efficacy at the sub -receptors, beneficial anxiolytic and antidepressant effects, reduced next day memory impairment and fewer residual effects .
Overall conclusions on grounds for re-examination: The Applicant presented with the grounds for re-examination a detailed argumentation eszopiclone based on nonclinical, pharmacokinetic and preliminary clinical pharmacology data in healthy volunteers .
Following eszopiclone re-examination of the available data the CHMP considered that there is overall insufficient evidence to demonstrate a clinical influence of the (R)- isomer removal on the safety and efficacy properties of (S)-zopiclone in patients with insomnia .
The pharmacological data provided by the Applicant based on the documented binding profile and on animal eszopiclone models cannot be extrapolated to predict clinical differences with respect to the racemate .
The differences observed lunesta dosage recommendation dosage for eszopiclone lunesta and alcohol eszopiclone glenmark in the pharmacokinetic clinical data provided by the Applicant are not based on identical doses and recalculation with correct doses reduces the size of effect on Tmax to about 10% .
Finally the newly provided data on neuropsychological effects in healthy volunteers (from a study that failed on primary analysis) are difficult to eszopiclone interpret and their clinical meaningfulness for patients with insomnia remains to be established .
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