Intellipharmaceutics meets 2012 goal for abuse-deterrent Oxycodone

theflyonthewall.com

Intellipharmaceutics International provided an update on its research and development activities and achievement of a goal in relation to its Rexista abuse-deterrent formulations for opioid and narcotic drugs. Intellipharmaceutics' previously announced development goals for 2012 included the completion of a pre-Investigational New Drug meeting with the FDA to discuss its Rexista oxycodone development plan. The company is pleased to advise that this meeting with a panel of the FDA's Center of Drug Evaluation and Research has been completed. As the company had planned, the meeting with FDA officials clarified the company's path going forward for its Rexista abuse-deterrent oxycodone development plan. Intellipharmaceutics will now plan to advance toward the next goals of its Rexista program, namely the manufacture of clinical batches of Rexista abuse-deterrent oxycodone product candidate under current good manufacturing practice conditions and the commencement of definitive Phase I clinical studies. This follows from the previous proof-of-concept Phase I clinical study completed on a pilot laboratory batch, which yielded positive results. There can be no assurance as to whether or when the FDA will approve any Intellipharmaceutics' application.

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