IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) announced that the FDA has accepted for filing the Company’s previously-announced New Drug Application (NDA) seeking authorization to market its RexistaTM abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths. The FDA has determined that the Company’s application is sufficiently complete to permit a substantive review, and has set a target action date under the Prescription Drug User Fee Act (PDUFA) of September 25, 2017.
RexistaTM is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The submission is supported by pivotal pharmacokinetic studies that demonstrated that RexistaTM is bioequivalent to OxyContin® (oxycodone hydrochloride extended release). The submission also includes abuse-deterrent studies conducted to support abuse-deterrent label claims related to abuse of the drug by various pathways, including oral, intra-nasal and intravenous, having reference to the FDA’s “Abuse-Deterrent Opioids — Evaluation and Labelling” guidance published in April 2015.
The abuse-deterrent properties incorporated into RexistaTM are designed to make the product unlikable and discourage or make it more difficult to manipulate for the purpose of abuse or misuse via common routes of administration including: ingestion following chewing, licking or crushing; insufflation; inhalation; or injection. If approved, RexistaTM may be the only abuse-deterrent oxycodone product with properties that may provide early warning of drug abuse if the product is manipulated or abused. The Company previously announced the results of a food effect study which showed that RexistaTM can be administered with or without a meal (i.e., no food effect), providing another point of differentiation from currently marketed oral oxycodone extended release products.
The CEO of Intellipharmaceutics, Dr. Isa Odidi, said, “The acceptance of filing of our NDA for RexistaTM represents an important step towards the commercialization of a potentially best—in-class abuse-deterrent oxycodone hydrochloride extended release product. We look forward to working with the FDA during their review of our NDA submission.”
There can be no assurance that we will not be required to conduct further studies for RexistaTM, that the FDA will ultimately approve the NDA for the sale of RexistaTM in the U.S. market, or that it will ever be successfully commercialized.
In the wake of the announcement, shares of Intellipharmaceutics are up nearly 17% to $3.50 in after-hours trading.
On the ratings front, IPCI has been the subject of a number of recent research reports. In a report issued on January 9, Aegis analyst Difei Yang reiterated a Buy rating on the stock, with a price target of $8.00, which represents a potential upside of 168% from last closing price. On November 25, Maxim’s Jason Kolbert reiterated a Buy rating on IPCI and has a price target of $6.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Difei Yang and Jason Kolbert have a yearly average return of 0.2% and a loss of -16.0% respectively. Yang has a success rate of 41% and is ranked #2524 out of 4373 analysts, while Kolbert has a success rate of 28% and is ranked #4310.
Intellipharmaceutics International, Inc. is a pharmaceutical company, which engages in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. Its patented Hypermatrix technology is a multidimensional controlled-release drug delivery platform that can be applied to the development of existing and new pharmaceuticals in the areas of neurology, cardiovascular, gastrointestinal tract, diabetes and pain.