Intellipharmaceutics International Inc. (IPCI)

[xr_biotech_consult]

The Company's NDA submission for RexistaTM was accepted for review by the FDA on February 2, 2017. The FDA set a target action date under the Prescription Drug User Fee Act ("PDUFA") of September 25, 2017. RexistaTM is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The submission is supported by pivotal pharmacokinetic studies that demonstrated that RexistaTM is bioequivalent to OxyContin® (oxycodone hydrochloride extended release). The submission also includes abuse-deterrent studies conducted to support abuse-deterrent label claims, having reference to the FDA's "Abuse-Deterrent Opioids — Evaluation and Labeling" guidance published in April 2015.