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Non-Inferiority 'Mistake' Hits E-Therapeutics' Depression Ambition

This article was originally published in Scrip

Executive Summary

"Our mistake was to structure the trial as a non-inferiority to amitriptyline study," e-Therapeutics CEO Malcolm Young told Scrip. "We should have called it a 'dose-ranging' study – which is what it was." The company saw its share price plummet on Feb. 15 following top-line results from its Phase IIb trial of ETS6103 (a controlled-release formulation of the analgesic tramadol) in major depressive disorder, which failed to meet its efficacy endpoint of establishing non-inferiority when compared to amitriptyline.

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