Meanwhile, positive BE data coming MID MAY!!!
TICK TOCK TICK TOCK
Elite Pharmaceuticals, Inc. Initiates Pivotal Bioequivalence Fed Study For Reformulated SequestOx™
NORTHVALE, N.J., March 13, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP), announced today that it has initiated pharmacokinetic testing of its reformulated SequestOx™. The reformulated product is expected to have a shorter Tmax under fed conditions. Elite is conducting a bioequivalence study which is a pivotal, open-label, randomized, single-dose, three-way, crossover study to evaluate the relative comparative bioavailability and bioequivalence of the modified formulation of SequestOx™ to the original formulation of SequestOx™ and to a comparator product under fed conditions. The study has enrolled forty-five healthy volunteers and the first subjects have been dosed.
SequestOx™ is Elite's investigational immediate-release oxycodone with sequestered naltrexone abuse-deterrent opioid product for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
"We are pleased to have this bioequivalence study underway for SequestOx™," commented Nasrat Hakim, President and CEO of Elite. "We are expecting results for this study by the middle of May and re-submitting the NDA prior to the end of the year."
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