Intellipharmaceutics International Inc. (IPCI)

[Derek0839]

I don't think that is necessarily true. I am more so worried about IPCI not getting the labels because of someone else's exclusivity, but I do believe Rexista meets the standards, it's just concerning not knowing what other exclusivity is out there. See this quote from the NDA acceptance...

"The submission also includes abuse-deterrent studies conducted to support abuse-deterrent label claims related to abuse of the drug by various pathways, including oral, intra-nasal and intravenous, having reference to the FDA's "Abuse-Deterrent Opioids — Evaluation and Labelling" guidance published in April 2015."

From the initial results it also states this which tells me it is abuse deterrent for injection and nasal and mentions of oral...

"The formulation is intended to present a significant barrier to tampering when subjected to various forms of anticipated physical and chemical manipulation commonly used by abusers. It is also designed to prevent dose dumping when inadvertently or intentionally co-administered with alcohol. In addition, when crushed or pulverized and hydrated, the proposed extended release formulation is designed to coagulate instantaneously and entrap the drug in a viscous hydrogel, which is intended to prevent syringing, injecting or sn"