In late December, Egalet Corporationn (NASDAQ:EGLT) submitted an NDA for its Arymo ER abuse-deterrent (AD) morphine tablet – a widely prescribed opiate with few AD competitors. Management expects to complete clinical trials in early 2017 to support a mid 2017 NDA filing for its AD oxycodone tablet. If approved, this will open Egalet to the $2.5bn market for oxycontin with a proprietary AD formulation.
Advancing development pipeline
Egalet is a specialty pharmaceutical company focused on pain and other conditions where it can use its abuse-deterrent technology to add value to generic drugs. Egalet submitted an NDA for its Arymo ER (Egalet-001) AD morphine tablet in December with and has been assigned a 14 October 2016 PDUFA date. The company is in late-stage trials for its oxycodone tablet (Egalet-002) and expects clinical readouts of intranasal (H216) and oral (H117) human abuse potential studies to support an NDA in mid-2017.
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