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Egalet plans NDA for oral morphine product

This article was originally published in Scrip

Executive Summary

Egalet said it plans to file a new drug application (NDA) by the end of 2015 for Egalet-001, an abuse-deterrent, extended-release, oral morphine product in development for the management of pain severe enough to require continuous opioid treatment. This comes after the US FDA provided feedback "supportive of Egalet's revised investigational plan designed to demonstrate bioequivalence (BE) of Egalet-001 to MS Contin," said the Wayne, PA-based firm. It also reported positive top-line results from a pivotal study (Study 067-EG-012) that demonstrated BE of Egalet-001 15mg and 30mg to MS Contin. Egalet is planning a pivotal 60 mg BE study which also will assess the effect of food on Egalet-001 by the end of this month. Egalet raised $50m in an IPO last year.

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