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March 31, 2014
08:29 EDTEGLTEgalet reports positive outcome of phase 1 of catagory 1 abuse deternt studies
Egalet announced positive results of the first phase of the category 1 abuse deterrence studies for Egalet-001, an abuse-deterrent, extended-release, oral morphine product in development for the treatment of moderate to severe chronic pain. The product uses Egalet's proprietary technology which is specifically designed to deter abuse by physical and chemical manipulation while also providing the ability to tailor the release of the active pharmaceutical ingredient. Egalet is conducting studies to evaluate Egalet-001's abuse-deterrent properties in accordance with the draft FDA Guidance titled "Abuse-Deterrent Opioids - Evaluation and Labeling." The first phase of the category 1 in vitro studies tested Egalet-001's ability to resist a broad range of common methods of physical manipulation, including crushing, cutting or grinding by using readily available items such as spoons, knives or coffee grinders for the purpose of abuse. The study results demonstrate that Egalet-001 resists the common forms of physical manipulation as compared to MS Contin. An independent laboratory tested a number of household tools in an effort to reduce the particle size for purposes of abuse. These results confirm tests previously conducted in Egalet's laboratory that showed Egalet-001's strong abuse-deterrence features.
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July 15, 2014
08:40 EDTEGLTEgalet reports positive top-line results from Category 1 abuse deterrence study
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