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March
27, 2008 - 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."
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