Intellipharmaceutics International has qualified its primary manufacturing equipment for the manufacture of an abuse-deterrent formulation of controlled-release oxycodone hydrochloride, and has begun the manufacture of clinical batches, a prerequisite for eligibility for Phase I studies, and to establish a clinical program in cooperation with the FDA to facilitate advancement of the drug through the application process.
The Rexista drug delivery platform, is a unique dosage form designed to deter abuse of oxycodone products, such as 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.
Dr. Isa Odidi, Intellipharmaceutics CEO, says 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."
In an initial pilot clinical trial designed to compare the pharmacokinetic characteristics of ReXista in a once-a-day 40mg dosage format with Purdue Pharma's "Oxycontin" product in a twice-a-day 20mg dosage format under fasted conditions, ReXista demonstrated sustained release pharmacokinetic activity, with blood plasma concentrations at clinically significant levels over a 24 hour period. The bioavailability of a single dose of ReXista, as measured by Cmax and AUC, was comparable to that of two doses of Oxycontin dosed at 12 hour intervals. Both Cmax and AUC were in the 80% - 125% range as compared to Oxycontin, demonstrating effective bioequivalence with the branded product.
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