FDA Grants Fast Track Designation For Rexista Oxycodone XR Incorporating PODRAS

(RTTNews) - Intellipharmaceutics International Inc. (IPCI) announced that the United States Food and Drug Administration or FDA has reviewed its request for Fast Track designation for its abuse deterrent Rexista Oxycodone XR extended-release tablets development program incorporating its Paradoxical OverDose Resistance Activating System and has concluded that it meets the criteria for Fast Track designation.

Fast Track is a designation assigned by the FDA in response to an applicant's request which meets FDA criteria. The designation mandates the FDA to facilitate the development and expedite the review of drugs intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs. This could potentially result in accelerated approval for Rexista Oxycodone XR thereby making it available to patients earlier than would be traditionally possible.

In March 2015, the company requested Fast Track designation for its novel, and potentially first-in-class, Rexista Oxycodone XR abuse deterrent oxycodone hydrochloride extended release tablets incorporating its PODRAS technology platform.

According to the company, a basis for the request was that Rexista Oxycodone XR has the potential to address an unmet medical need, namely the prevention, deterrence or reduction of the abuse of oxycodone HCl extended release solid oral dosage forms involving the deliberate or inadvertent oral ingestion of more intact pills or tablets than prescribed to achieve a feeling of euphoria. This is a very common and serious form of drug abuse.