IntelliPharmaCeutics Announces Successful Completion of a Pilot Clinical Trial for its Abuse and Alcohol Resistant Sustained Release Oxycodone



    TORONTO, March 27 /CNW/ - 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."

    About IntelliPharmaCeutics
    --------------------------

    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. For more information about
IntelliPharmaCeutics, visit the Company's web site at
www.intellipharmaceutics.com.

    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.





For further information:

For further information: John N. Allport, V.P. - Legal Affairs and
Licensing, Tel: (416) 798-3001, E-mail: jallport@intellipharmaceutics.net;
Sharon Will, Investor Relations, Tel: (352)-595-1391, E-mail:
sharon@saggicapital.com

Organization Profile

INTELLIPHARMACEUTICS CORP.

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