Egalet Corporation a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions announced the issuance of a United States patent covering OXAYDO® (oxycodone HCI, USP) tablets for oral use only–CII. Egalet licensed OXAYDO from Acura Pharmaceuticals and launched the product in the United States in September 2015.
The United States Patent and Trademark Office (USPTO) issued patent 9,492,443 broadly covering immediate-release pharmaceutical compositions comprising an opioid formulated with Acura Pharmaceutical’s proprietary Aversion® Technology intended to discourage common routes of abuse, including snorting. The patent offers protection through 2024.
“This newly issued patent strengthens the overall protection for OXAYDO and will be listed in the Orange Book alongside five other patents covering OXAYDO,” said Bob Radie, president and chief executive officer of Egalet. “Issuance of this patent further highlights the uniqueness of the OXAYDO formulation, the only approved immediate-release oxycodone designed to discourage abuse via one of the most common routes of oxycodone abuse—snorting.”
OXAYDO is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. OXAYDO is the first and only immediate release oxycodone product designed to discourage abuse via snorting because of an inactive ingredient that may cause nasal burning if OXAYDO is manipulated. 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.
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. Egalet has two approved products: OXAYDO® (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using its proprietary Guardian™ Technology, Egalet is developing a pipeline of clinical-stage, product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, ARYMO™ ER, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Egalet’s 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. For additional information on Egalet, please visit egalet.com. For full prescribing information on SPRIX, including the boxed warning, please visit www.sprix.com
For full prescribing information on OXAYDO
E. Blair Clark-Schoeb
Senior Vice President, Communications