Egalet (EGLT) Files sNDA for OXAYDO with U.S. FDA

December 1, 2016 1:51 PM EST

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Egalet Corporation (Nasdaq: EGLT) announced that the company has submitted to the U.S. Food and Drug Administration (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.

Immediate-release opioids account for 90 percent of the total U.S. opioid market. An estimated 91 percent of all prescription opioid abusers have abused immediate-release opioids. There are currently no abuse-deterrent, IR opioids on the market today.

"The submission of this supplemental NDA for OXAYDO is part of our broader strategy to strengthen and expand the label for OXAYDO," said Jeffrey Dayno, MD, chief medical officer at Egalet. "With the issue of abuse of immediate-release opioids receiving more attention recently, we look forward to working with the FDA as they review the data submitted in this supplement."

OXAYDO is the first and only immediate-release oxycodone product designed to discourage intranasal abuse. Through its novel, patent protected formulation, OXAYDO contains an inactive ingredient that may cause nasal burning if OXAYDO is manipulated and snorted. In an intranasal human abuse potential double-blind, crossover study, six times more recreational users reported they would not take OXAYDO again compared to subjects exposed to immediate-release oxycodone (30 percent of subjects exposed to OXAYDO responded they would not take the drug again compared to five percent of subjects exposed to IR oxycodone). The clinical significance of the difference in drug liking and difference in response to taking the drug again reported in this study has not yet been established. There is no evidence that OXAYDO has reduced abuse liability compared to immediate-release oxycodone.

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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