Egalet submits FDA application to expand label for Oxaydo
Egalet announced it has submitted to the U.S. FDA a supplemental new drug application for Oxaydo tablets C-II to support an abuse-deterrent label claim for the intravenous route of abuse. Oxaydo is an immediate-release 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 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. "There are currently no abuse-deterrent, IR opioids on the market today," the company noted. "With the issue of abuse of immediate-release opioids receiving more attention recently, we look forward to working with the FDA," chief medical officer Jeffrey Dayno commented. The sNDA will be a standard FDA review which carries a six-month review timeline.