IntelliPharmaCeutics Announces Successful Completion of a PilotClinical Trial for its Abuse and Alcohol Resistant SustainedRelease Oxycodone
TORONTO, March 27, 2008 /PRNewswire/ - IntelliPharmaCeutics Ltd. (Delaware) is pleased to announce 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 ("IntelliPharmaCeutics" or the "Company"). 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. Dr. Isa Odidi, CEO and Chief Design Officer for IntelliPharmaCeutics, stated "We are very encouraged by these early results. The ReXista(TM) delivery technology was developed entirely in-house, and is unique in the industry. We are excited that our new ReXista(TM) dosage form, which resists dose-dumping in the presence of alcohol, and which has great potential to resist oral, nasal and intravenous abuse, has already demonstrated controlled release to a once-a-day standard and effective bioequivalence with the twice daily branded product. With these results in hand, we will certainly move rapidly to advance the development into a full clinical trial program. We will also now apply the Rexista(TM) technology to other narcotic analgesic agents in our development pipeline."
IntelliPharmaCeutics is a drug delivery innovator and developer, specializing in the controlled and targeted once-a-day delivery of oral, solid dose pharmaceutical products. It operates from a 25,000 sq ft research laboratory and manufacturing scale-up facility located adjacent to Toronto International Airport. The Company utilizes proprietary, patented and proven drug delivery technologies, to formulate both generic and new drug products with enhanced performance characteristics. In addition to its pre-clinical portfolio, IntelliPharmaCeutics has an extensive pipeline of development products in clinical trials, in therapeutic areas that include neurology, cardiovascular, GIT, and pain.
This news release contains forward-looking statements, including those related to the preliminary nature of clinical program results and the potential for further product development, that involve known and unknown risks, delays, uncertainties and other factors not under the control of IntelliPharmaCeutics, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. In particular, because substantial future clinical testing and regulatory review will be required prior to marketing approval, there can be no certainty that a successful commercial product will be developed. The Company undertakes no obligation to update any forward-looking statements.
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Posted: March 2008