IntelliPharmaCeutics (IPCI) Rexista NDA Filing Expected, But 'Very Good News' - Maxim Group
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Intellipharmaceutics (IPCI) Files NDA with FDA for Abuse Deterrent Opioid Analgesic Rexista
November 25, 2016 7:47 AM ESTIntellipharmaceutics International Inc. (Nasdaq : IPCI) filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking authorization to market its Rexista® abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
Rexista® 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 Rexista® is bioequivalent to OxyContin® (oxycodone hydrochloride extended release). The submission also includes a... More