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March 25, 2014
08:17 EDTEGLTEgalet initiates bioequivalence studies for abuse-deterrent morphine Egalet-001
Egalet announced the initiation of the bioequivalence, or BE, program for Egalet-001, an abuse-deterrent, extended-release, oral morphine product in development for the treatment of moderate to severe chronic pain. These studies are intended to establish bioequivalence of Egalet-001 to MS Contin. The bioequivalence program consists of three studies, all examining the bioequivalence of Egalet-001 compared to MS Contin. Egalet plans to seek approval of Egalet-001 under the FDA's Section 505(b)(2) regulatory pathway, and has received Fast Track designation for Egalet-001 which could afford greater access to the FDA for the purpose of expediting Egalet-001's development, review and potential approval. Egalet intends to rely on the FDA's previous conclusions of safety and efficacy for MS Contin, and does not expect that any additional preclinical studies or clinical trials will be required for Egalet-001. Egalet anticipates submitting an NDA in Q4 and if approved by the FDA, commencing sales and marketing of the product in the second half of 2015.
News For EGLT From The Last 14 Days
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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 This Category 3 abuse-deterrent HAL study was conducted in accordance with the FDA draft guidance on Abuse-Deterrent Opioids: Evaluation and Labeling.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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