Intellipharmaceutics International Inc. (IPCI)

[BondsSF]

"The notification from the FDA stated that the Company will not be required to conduct Phase III studies if bioequivalence to Oxycontin(TM) is demonstrated."

The bioequivalence required only has to do with Oxycontin so the PODRAS has NOTHING to be bioequivalent to.

I contacted the company asking them if a Phase 3 will be needed with the PODRAS added and will let you know what they respond.


"We are pleased with the grant by the FDA of Fast Track status for Rexista(TM) Oxycodone XR incorporating our proprietary PODRAS(TM) technology which is being formulated to decrease the 'liking' of dose escalation and decrease or delay the attendant risk of respiratory depression in drug-naive individuals. The development of this product candidate could, if successful, decrease the desirability of taking more intact tablets than prescribed, potentially addressing an unmet need and possibly resulting in fewer accidental or intentional deaths," stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. "To the best of our knowledge, no other product currently approved for sale in the U.S. or Canada has demonstrated this potential."