Pharma group Intellipharmaceutics International Inc (NASDAQ:IPCI) has filed a new drug application (NDA) with the powerful US Food and Drug Administration (FDA) so it can market a treatment for severe pain.
Rexista is aimed at managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are not good enough.
Chief executive Dr Isa Odidi told investors: “The NDA submission of Rexista represents a critical milestone and turning point for the company.
"This is our first NDA submission and the first abuse-deterrent oxycodone product candidate we are aware of that not only resists common forms of abuse but provides a preventive tool that may flag early warning of abuse.
"We are excited about the prospect of Rexista, if approved, having a positive impact in addressing the opioid epidemic."
The firm reckons its abuse-deterrent and overdose prevention technologies are best in class and it is looking forward to further expanding its development program for abuse-deterrent pain and other medications.
"The company has identified potential manufacturing partners and is currently evaluating various manufacturing options for Rexista in the US. We look forward to working with the FDA during their review of our NDA submission," added Odidi.
The abuse-deterrent properties in Rexista are designed to make it unlikable and discourage its misuse through such things as chewing, licking, inhalation , or injecting.