Shares of Intellipharmaceutics International (NASDAQ: IPCI) are slightly higher following news late yesterday that the FDA has accepted the company’s filing of a New Drug Application (NDA) for Rexista™ for the management of moderate to severe pain. Pivotal pharmacokinetic and abuse-deterrent studies have shown Intellipharmaceutics’ Rexista as bioequivalent to OxyContin®. “The acceptance of filing of our NDA for Rexista™ 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,” Intellipharmaceutics CEO Dr. Isa Odidi stated in the news release. Following yesterday’s news, Aegis Capital reiterated its ‘Buy’ rating and price target of $8 on the company’s stock.
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About Intellipharmaceutics
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. The company’s patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (some of which have received FDA approval) and product candidates in various stages of development, including Abbreviated New Drug Application filed with the FDA (and one Abbreviated New Drug Submission filed with Health Canada) in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain. Intellipharmaceutics also has NDA 505(b)(2) specialty drug product candidates in its development pipeline. These include Rexista® (abuse deterrent oxycodone hydrochloride extended release tablets), based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules). The company’s current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. The company has increased its research and development emphasis towards new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both Rexista® and Regabatin™. For more information, visit www.intellipharmaceutics.com.
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