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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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January 26, 2015
07:52 EDTEGLTEgalet price target raised to $18 from $12 at Canaccord
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January 22, 2015
08:09 EDTEGLTEgalet reports HAL study of Egalet-001 met primary endpoint
Egalet announced positive results from a Category 3 human abuse liability, or HAL, study of Egalet-001, an abuse-deterrent, extended-release, oral morphine formulation in late-stage clinical development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The clinical HAL study demonstrated that in nondependent, recreational opioid users, the abuse potential of manipulated Egalet-001 taken orally was significantly lower than that for manipulated MS Contin. This Category 3 abuse-deterrent HAL study was conducted in accordance with the FDA draft guidance on Abuse-Deterrent Opioids: Evaluation and Labeling. It was a single-center, randomized, double-blind, double-dummy, four-way crossover study which assessed the abuse potential of Egalet-001 versus MS Contin in 38 nondependent, recreational opioid users when taken orally. The primary objective was to compare the relative abuse potential of intact and manipulated formulations of Egalet-001 versus manipulated MS Contin. Since Egalet-001 is extremely hard and difficult to chew, the manipulation of the product involved a series of maneuvers using different household tools to try and reduce the particle size to maximally defeat the tablet. This procedure was based on the outcome of the first phase, physical tampering, of the Category 1 abuse-deterrent studies for Egalet-001. In addition to this Category 3 HAL study, Egalet presented positive results from Category 1 studies for Egalet-001 last year at PainWeek and will share the results from additional abuse-deterrent studies later this year.

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