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Egalet-002 is an abuse-deterrent, extended-release, oral formulation of oxycodone developed for the management of pain severe enough to require daily, around-the-clock opioid treatment when alternative treatments are inadequate. It utilizes Egalet’s proprietary Guardian Technology, which employs a unique plastic injection molding process to create tablets that are highly resistant to physical and chemical manipulation. This design aims to deter common methods of opioid abuse such as crushing, chewing, or dissolving the tablet for rapid release or misuse. Clinical studies have demonstrated that Egalet-002 does not exhibit alcohol-induced dose dumping—a safety concern with some extended-release opioids—making it potentially safer in patients who may consume alcohol. The product was granted Fast Track designation by the FDA and has undergone late-stage clinical development for moderate-to-severe pain[1][2][4][5][6].
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