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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.
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June 29, 2015
06:09 EDTEGLTEgalet announces positive top-line results from Egalet-001 study
Egalet announced positive results from a Category 3 intranasal 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 intranasally was significantly lower than that for manipulated MS Contin. Bob Radie, president and CEO at Egalet, stated, "With this strong intranasal HAL data combined with the previously announced positive oral HAL data, and the category 1 studies, Egalet-001 continues to demonstrate a very promising abuse-deterrent profile. With this data, we have successfully completed the clinical studies necessary to file our NDA for Egalet-001, which we plan to submit in Q4."
June 25, 2015
06:10 EDTEGLTEgalet Egalet-001 demonstrates bioequivalence at 60 mg dose
Egalet announced top-line results from a pivotal pharmacokinetic study demonstrating bioequivalence of Egalet-001 60 mg to MS Contin 60 mg. Egalet-001 is an abuse-deterrent, extended-release, oral morphine product in late-stage development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. In addition to this 60 mg bioequivalence study, Egalet announced in March top-line results from another pharmacokinetic study which demonstrated bioequivalence of Egalet-001 15 mg and 30 mg to comparable doses of MS Contin.

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