Supplemental new drug application for Oxaydo (oxycodone HCl, USP) filed with FDA for pain treatment
Egalet Corporation has submitted to the FDA a supplemental new drug application (sNDA) for Oxaydo (oxycodone HCl, USP) tablets C-II to support an abuse-deterrent label claim for the intravenous route of abuse. The sNDA includes Category 1 in vitro data that demonstrate Oxaydo resists extraction of oxycodone and, based on its gelling properties, is more difficult to draw into a syringe compared to a non-abuse-deterrent immediate-release (IR) oxycodone comparator.
Oxaydo is an IR oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.
The sNDA for Oxaydo includes data from a series of Category 1 studies that were presented at PAINWeek 2016. The sNDA will be a standard FDA review which carries a six-month review timeline.
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