|IntelliPharmaCeutics Intl Inc (USA)(NASDAQ:IPCI): FDA Grants Fast Track Designation for Rexista Oxycodone XR Incorporating PODRAS(TM) Technology|
|By Josh Gee|
|Wednesday, 27 May 2015 18:37|
Pharmaceutical firm IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) has confirmed that the United States Food and Drug Administration (“FDA”) has assessed the firm’s request for Fast Track designation of its abuse deterrent Rexista Oxycodone XR extended-release tablets development program that would have the Paradoxical OverDose Resistance Activating System.
Fast Track designation is given by FDA when an applicant meets FDA criteria. For this, it is necessary that FDA helps in expediting review of drugs aimed for treating life threatening conditions as well as shows potential of addressing unmet medical needs.
This may lead to accelerated approval for Rexista Oxycodone XR making it available for patients than it would be traditionally possible.
The firm sought Fast Track designation for the novel and potentially first-in-class, Rexista Oxycodone XR abuse deterrent oxycodone hydrochloride extended release tablets.
Rexista has potential of addressing an unmet medical especially prevention or reduction of abuse of oxycodone HCl involving deliberate oral ingestion of more intact pills to achieve a feeling of euphoria.
Rexista Oxycodone XR is aimed for managing moderate to severe pain when an analgesic is needed for extended period of time.
Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics, opined that it is pleased with the grant of FDA for Rexista Oxycodone XR incorporating the proprietary PODRAS technology that would delay the attendant risk of respiratory depression in drug-naive individuals.
He added that the development of the product would lower desirability of taking more tablets than potentially addressing and possibly leading to fewer accidental deaths. There is no surety that the firm would be having a faster development process vis-a-vis conventional FDA standards or whether the firm’s Rexista Oxycodone XR product candidate would be approved on a commercial scale.