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March 25, 2014
08:17 EDTEGLTEgalet initiates bioequivalence studies for abuse-deterrent morphine Egalet-001
Egalet announced the initiation of the bioequivalence, or BE, program for Egalet-001, an abuse-deterrent, extended-release, oral morphine product in development for the treatment of moderate to severe chronic pain. These studies are intended to establish bioequivalence of Egalet-001 to MS Contin. The bioequivalence program consists of three studies, all examining the bioequivalence of Egalet-001 compared to MS Contin. Egalet plans to seek approval of Egalet-001 under the FDA's Section 505(b)(2) regulatory pathway, and has received Fast Track designation for Egalet-001 which could afford greater access to the FDA for the purpose of expediting Egalet-001's development, review and potential approval. Egalet intends to rely on the FDA's previous conclusions of safety and efficacy for MS Contin, and does not expect that any additional preclinical studies or clinical trials will be required for Egalet-001. Egalet anticipates submitting an NDA in Q4 and if approved by the FDA, commencing sales and marketing of the product in the second half of 2015.
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