IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration (“FDA”) has reviewed the Company’s request for Fast Track designation for its abuse deterrent Rexista™ Oxycodone XR (Oxycodone HCl) extended-release tablets development program incorporating its Paradoxical OverDose Resistance Activating System (“PODRAS™”) 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. 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.
Rexista™ Oxycodone XR is intended for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Such medications are considered important in the treatment of chronic pain, but have the potential for abuse.
“We are pleased with the grant by the FDA of Fast Track status for Rexista™ Oxycodone XR incorporating our proprietary PODRAS™ 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.”
There can be no assurance that the Company will, as a result of the Fast Track designation for Rexista™ Oxycodone XR, experience a faster development process or review, compared to conventional FDA standards, or that the Company’s Rexista™ Oxycodone XR product candidate will be approved at all, or that it will ever be successfully commercialized. (Original Source)
Shares of Intellipharmaceutics closed last Friday at $3.10. IPCI has a 1-year high of $4.19 and a 1-year low of $1.94. The stock’s 50-day moving average is $2.86 and its 200-day moving average is $2.60.
On the ratings front, Intellipharmaceutics has been the subject of a number of recent research reports. In a report issued on May 21, Maxim Group analyst Jason Kolbert reiterated a Buy rating on IPCI, with a price target of $7, which implies an upside of 125.8% from current levels. Separately, on the same day, Brean Murray Carret’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $8.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Jonathan Aschoff have a total average return of 1.5% and 7.6% respectively. Kolbert has a success rate of 43.1% and is ranked #1545 out of 3608 analysts, while Aschoff has a success rate of 56.3% and is ranked #413.
IntelliPharmaCeutics International Inc is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs.