TORONTO, Aug. 28, 2014 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), 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 an enhancement of its Rexista™ abuse-deterrence technologies with a significant improvement designed to prevent overdose when more pills than prescribed are swallowed intact. Intellipharmaceutics' new platform technology is branded PODRAS™ (Paradoxical OverDose Resistance Activating System).
The PODRAS™ platform technology is covered by patents pending with the U.S. Patent and Trademark office.
"We believe this significant advance in our abuse deterrence technology has the potential to positively differentiate Rexista™ from other abuse-deterrent technologies of which we are aware, and represents an important step toward helping patients manage their pain safely," said Dr. Isa Odidi, Chief Executive Officer of Intellipharmaceutics. "In addition to its use with oxycodone, the new technology is potentially applicable to a wide range of drug products that are intentionally or inadvertently abused and cause harm by overdose to those who ingest them."
Intellipharmaceutics' most advanced application of the PODRAS™ platform to date is to its Rexista™ product candidate (oxycodone hydrochloride extended-release tablet), which is designed to deter abuse by both physical interference and overdose.
Preclinical studies of Rexista™ suggest that, unlike other third-party abuse-deterrent oxycodone products, if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected, even possibly approaching zero. However, if the prescribed number of pills is swallowed, the drug release should be as expected.
In January 2013, the United States Food and Drug Administration ("FDA") published a paper titled, Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling, which cited the need for more efficacious abuse deterrence-technology.
In this draft Guidance, the FDA stated, "Opioid analgesics are often manipulated for purposes of abuse. Most abuse-deterrent technologies developed to date are designed to make product manipulation more difficult or to make abuse of the manipulated product less attractive or rewarding. However, these technologies have not yet proven successful at deterring the most common form of abuse – swallowing a number of intact pills or tablets to achieve a feeling of euphoria."
Dr. Ed Sellers, an internationally recognized clinical pharmacologist and Professor Emeritus, University of Toronto, and President of DL Global Partners commented "The risk of overdose due to taking more opiate analgesic than prescribed is a real one. The lack of delivery technologies to reduce that risk is an unmet public health need. The announced technology is promising. Confirmation of its clinical importance in human clinical studies would be a significant contribution to deterring abuse."
Intellipharmaceutics currently expects to begin a series of clinical trials in Canada and the United States in the coming months to further evaluate Rexista™ incorporating its PODRAS™ platform.
There can be no assurance as to whether or when the FDA will approve any Intellipharmaceutics' Rexista™ oxycodone application.
About Rexista™ Oxycodone
Rexista™ oxycodone is an investigational drug, with a unique long-acting oral formulation of oxycodone intended to treat moderate-to-severe pain when a continuous, around the clock opioid analgesic is needed for an extended period of time. Rexista™ oxycodone is designed to discourage common methods of tampering associated with misuse and abuse of such prescription opioid analgesic.
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 (our dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths) and product candidates in various stages of development, including Abbreviated New Drug Applications ("ANDAs") filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has New Drug Application 505(b)(2) product candidates in its development pipeline. These include Rexista™ oxycodone, an abuse-deterrent oxycodone, based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System, and PODRAS™ Paradoxical Overdose Resistance Activating System, and Regabatin™ XR pregabalin extended-release capsules.
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