IntelliPharmaCeutics Announces Completion of Clinical Trial for its Abuse and Alcohol Resistant Sustained Release Oxycodone
IntelliPharmaCeutics Ltd. announced significant results from a recently completed pilot clinical trial for its new abuse-resistant, alcohol-resistant once-a-day oral oxycodone formulation by its operating company IntelliPharmaCeutics Corp. of Toronto. The product is covered by pending patent applications for its novel ReXista(TM) abuse and alcohol resistant drug delivery technology. It is one of the Company's line of in-house analgesic products in development for the management of moderate to severe chronic and acute pain.
The ReXista(TM) oxycodone product is a novel dosage form, designed to be resistant to abuse by oral ingestion when crushed or chewed, by injection when combined with solvents, and by nasal application when crushed or powdered. The abuse of this important pain relief drug has been well documented over many years.
The ReXista(TM) oxycodone product is also designed to resist release of the entire daily dose when consumed with alcohol in any quantity, a problem so serious with some opioid drugs such as hydromorphone that their use has been limited or curtailed by the FDA.
The product has been subjected to rigorous in-vitro testing and has met its design criteria for dissolution profiles and in-vitro resistance to simulated abuse. Based on these initial results, the product is expected to be effective for once-a-day dosing in the management of pain. It is also expected that it will resist abuse by oral, nasal or intravenous administration and resist unintended total dose release in the presence of alcohol.
The initial pilot clinical trial was designed to compare the pharmacokinetic characteristics of the IntelliPharmaCeutics ReXista(TM) oxycodone product, in a once-a-day 40mg dosage format, with a currently marketed branded oxycodone product, Purdue Pharma's Oxycontin(R), in a twice-a-day 20mg dosage format, under fasted conditions.
The pilot clinical trial produced the following results:
- The ReXista(TM) product 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 the ReXista(TM) product, as measured by Cmax and AUC, was comparable to that of two doses of Oxycontin(R) dosed at 12 hour intervals. Both Cmax and AUC were in the 80% - 125% range as compared to Oxycontin(R), demonstrating effective bioequivalence with the branded product.
The Company intends to release detailed results of this pilot clinical trial after further study and analysis.
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