Catalyst

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Having now demonstrated bioequivalence for its Rexista Oxycodone XR product, Intellipharmaceutics intends to file a New Drug Application within the next 6 months

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Management Comment "We take great pride in being the first pharmaceutical company, to the best of our knowledge, to have demonstrated bioequivalence in both fasted and fed conditions to the brand reference drug Oxycontin®. This enables us to accelerate the development and commercialization of our abuse deterrent Rexista™ Oxycodone XR product candidate without the need for costly and time-consuming Phase III efficacy trials," stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. "We look forward to filing an NDA within the next six months, which we hope will lead to a positive contribution in addressing an unmet need in opioid abuse and addiction."
http://www.intelliph...
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Catalyst Date
Occurred on:
Jul 05, 2016
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Related Keywords Bioequivalence, Rexista Oxycodone Xr, Nda