Egalet Corp. of Pennsylvania recently obtained a complete response letter from the U.S. Food and Drug Administration about its Oxaydo (oxycodone HCl, USP) tablets in 10 mg and 15 mg dosage strengths.
Following its prior approval supplement, the FDA asked for additional details on the impact of food with the 15 mg dose as well as more information about intranasal abuse-deterrent characteristics of the product in both dosages. Egalet stated via its website that it intends to collaborate with the FDA to establish the best course of action.
Oxaydo works as an immediate-release medication to manage acute and chronic moderate to severe pain in cases determined to be appropriate for opioid analgesic treatment, company spokespersons stated.
Originally approved in December 2015 in 5 mg and 7.5 mg strengths, the product was designed to inhibit intranasal abuse by inclusion of inactive ingredients that can trigger nasal burning if altered and/or snorted. Egalet has made no claim regarding diminished abuse statistics.
“Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles,” the company said.
Egalet is a fully integrated specialty pharmaceutical company that develops, manufactures and markets pain treatments. Its products include Oxaydo, Sprix nasal spray and Arymo ER tablets. Egalet developed its proprietary Guardian Technology in conjunction with its pain management product portfolio.