Intellipharmaceutics Submits
Investigational New Drug Application to the U.S. FDA for IPCI006
(oxycodone hydrochloride immediate release) Tablets Incorporating
its Abuse Deterrent and Overdose Resistant
Technology
Toronto, Ontario, November 27, 2018 Intellipharmaceutics
International Inc. (NASDAQ and TSX:IPCI)
("Intellipharmaceutics" or the "Company"), a pharmaceutical company
specializing in the research, development and manufacture of novel
and generic controlled-release and targeted-release oral solid
dosage drugs, today announced that it has submitted an
investigational new drug (“IND”) application to the
U.S. Food and Drug Administration (“FDA”) for its
oxycodone hydrochloride immediate release (“IPCI006”)
tablets in the 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
strengths.
Oxycodone
hydrochloride is indicated for the management of moderate to severe
pain where the use of an opioid analgesic is
appropriate.
This
novel drug formulation incorporates the Company’s Paradoxical
OverDose Resistance Activating System (“PODRAS™”)
delivery technology and its novel Point Of Divergence Drug Delivery
System (“nPODDDS™”) technology.
IPCI006
is designed to prevent, delay or limit the release of oxycodone
hydrochloride when more intact tablets than prescribed are
ingested, thus delaying or preventing overdose and allowing for
sufficient time for a rescue or medical intervention to take place.
It is also intended to present a significant barrier to abuse by
snorting, “parachuting”, injecting or smoking finely
crushed oxycodone hydrochloride immediate release
tablets.
The
data generated from the studies conducted under this IND is
expected to form part of a new drug application (“NDA”)
seeking FDA approval for IPCI006 tablets.
If
approved, IPCI006 may be the first immediate release formulation of
oxycodone hydrochloride intended to simultaneously prevent or delay
overdose and prevent abuse by intranasal or intravenous
routes.
The CEO
of Intellipharmaceutics, Dr. Isa Odidi, said, “We believe
IPCI006 not only will demonstrate the strength of our
abuse-deterrent technologies, but also the value of our portfolio
of oxycodone hydrochloride product candidates. We are particularly
excited at the potential of having the first immediate release
formulation of oxycodone hydrochloride tablets focused on
presenting a barrier to abuse through overdose by taking multiple
tablets, abuse through intranasal inhalation and abuse through
intravenous injection – in one
formulation.”
According
to Symphony Health Solutions Corporation, U.S. sales of oxycodone
hydrochloride immediate release for the 12 months ended October 31,
2018 were approximately $710 Million (in TRx MBS Dollars, which
represents projected new and refilled prescriptions representing a
standardized dollar metric based on manufacturer's published
catalog or list prices to wholesalers and does not represent actual
transaction prices and does not include prompt pay or other
discounts, rebates or reductions in price).
There can be no assurance
that we will be successful in
submitting any NDA with the FDA, that the FDA will approve the
Company’s IPCI006 product candidate for sale in the U.S.
market or any related abuse-deterrent label claims, or that it will
ever be successfully commercialized and produce significant revenue
for us.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a
pharmaceutical company specializing in the research, development
and manufacture of novel and generic controlled-release and
targeted-release oral solid dosage drugs. The Company's patented
Hypermatrix
™
technology
is a multidimensional controlled-release drug delivery platform
that can be applied to a wide range of existing and new
pharmaceuticals. Intellipharmaceutics has developed several drug
delivery systems based on this technology platform, with a pipeline
of products (some of which have received FDA approval) in various
stages of development. The Company has abbreviated new drug
application (
“
ANDA
”
) and NDA 505(b)(2) drug product
candidates in its development pipeline. These include the
Company
’
s abuse-deterrent
oxycodone hydrochloride extended release formulation
(“Oxycodone ER”) based on its proprietary
nPODDDS
™
drug delivery
system (for which an NDA has been filed with the FDA), and
Regabatin
™
XR (pregabalin
extended-release capsules).
Cautionary Statement Regarding Forward-Looking
Information
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Trademarks used herein are the property of their respective
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Unless the context otherwise requires, all references to "we,"
"us," "our," "Intellipharmaceutics," and the "Company" refer to
Intellipharmaceutics International Inc. and its
subsidiaries.
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herein is provided as is, and Symphony makes no representation
and/or warranty of any kind, including but not limited to, the
accuracy and/or completeness of such information.
CONTACT INFORMATION
Company
Contact:
Intellipharmaceutics
International Inc.
Andrew
Patient
Chief
Financial Officer
416.798.3001
ext. 106
investors@intellipharmaceutics.com
Investor
Contact:
ProActive
Capital
Kirin
Smith
646.863.6519
ksmith@pcgadvisors.com