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Elite to pause SequestOx trial
August 2017
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NORTHVALE, N.J.—July saw Elite Pharmaceuticals Inc. share top-line results from its pivotal bioequivalence fed study for SequestOx, an investigational immediate-release oxycodone with sequestered naltrexone abuse-deterrence opioid product being developed for moderate to severe acute pain. One of the key objectives was assessing whether the reformulated SequestOx had a similar Tmax to the comparator drug, Roxicodone, when taken with a high-fat meal. In the study, the mean Tmax for SequestOx was 4.6 hours with a range of 0.5 hour to 12 hours. The mean Tmax of Roxicodone was 3.4 hours with a range of 0.5 hour to 12 hours. Elite intends to pause rather than proceeding with additional clinical trials, and will confer with the FDA to determine its next steps for immediate-release SequestOx.

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