Intellipharmaceutics Announces Significant Advance In Its Abuse-Deterrent Oxycodone Program
TORONTO, May 20, 2010 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) today announced that it has achieved a significant advance in its program to develop and manufacture drugs incorporating abuse-deterrent characteristics. The Company advises that it has taken delivery of and fully qualified its primary manufacturing equipment for the manufacture of an abuse-deterrent formulation of controlled-release oxycodone hydrochloride, and that the manufacture of clinical batches using that equipment has commenced. The successful manufacture of clinical batches is required to make the drug eligible for Phase I studies, and to establish a clinical program in cooperation with the FDA in order to facilitate advancement of the drug through the application process .
The drug delivery platform, branded Rexista™, produces a unique dosage form designed to be deterrent to the well-documented abuses associated with currently marketed oxycodone products, such as the abuse of these drugs by nasal inhalation when crushed or powdered, and by injection when combined with solvents. Rexista™ products are also designed to deter release of the entire dose when consumed with alcohol, a significant problem with some opioid drugs. In 2008, controlled-release oxycodone drugs had U.S. sales of approximately $2 billion.
Dr. Isa Odidi, CEO of Intellipharmaceutics, stated that "the qualification of this equipment is a significant step in our Rexista program. It involved the very difficult design and modification of certain aspects of the equipment to accommodate the novel and proprietary dosage form which we have developed for our Rexista drug program, namely a paste in a capsule. We have now commenced the manufacture of clinical batches of our oxycodone CR product using this novel delivery platform. The overall success we are having, including with Rexista and our two filed ANDAs for generics of Focalin XR and Effexor XR, is reflective of the capabilities and versatility of our proprietary technology platforms and our scientific and regulatory teams."
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