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Egalet Corp reports positive outcome of first phase of Category 1 Abuse Deterrence Studies for Egalet-001


Monday, 31 Mar 2014 08:01am EDT 

Egalet Corp: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.Says the product uses Egalet's 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 (API).Says conducting studies to evaluate Egalet-001's abuse-deterrent properties in accordance with the draft FDA Guidance titled 'Abuse-Deterrent Opioids - Evaluation and Labeling.Says 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.Says the study results demonstrate that Egalet-001 resists the common forms of physical manipulation as compared to MS Contin (morphine sulfate controlled-release) (MS Contin).Says an independent laboratory tested a number of household tools (electrical and non-electrical) in an effort to reduce the particle size for purposes of abuse.