Egalet Submits sNDA to the FDA for Abuse-Deterrent Oxaydo

Egalet has submitted a supplemental new drug application (sNDA) to the FDA for Oxaydo, (oxycodone HCl, USP) in favor of an abuse-deterrent label claim for the intravenous route of abuse. The company submitted the sNDA with category 1 in vitro data that show Oxaydo resists the extraction of oxycodone.

Because of its gelling properties, Oxaydo is more difficult to draw into a syringe. The product is an oral formulation of oxycodone HCI for the management of acute and chronic moderate-to-severe pain. Specifically, it’s prescribed to patients when the use of an opioid analgesic is appropriate.

The most common adverse reactions associated with Oxaydo are nausea, constipation, vomiting, headache, insomnia, pruritus, dizziness, asthenia, and somnolence. However, some severe effects may occur, such as respiratory depression, respiratory arrest, or shock.

"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, in a press release. "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 an inactive ingredient that may cause nasal burning if it is manipulated and snorted. In a double-blind study, 6 times more recreational users stated that they would not take Oxaydo again compared to study participants who were exposed to immediate-release oxycodone.