IntelGenx Receives Complete Response Letter from FDA for RIZAPORT® NDA
April 02 2019 - 8:00AM
IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leading
oral drug delivery company, today announced it has received a
Complete Response Letter (“CRL”) from the U.S. Food and Drug
Administration (“FDA”) regarding its resubmitted 505(b)(2) New Drug
Application (“NDA”) for RIZAPORT® VersaFilm™ for the treatment of
acute migraines.
The issues cited in the CRL relate to the
Chemistry, Manufacturing and Controls section of the application.
The Agency requested additional information, but no new
bioequivalence study.
"We believe the recommendations stated in the
CRL are manageable and we remain committed to working closely with
the FDA to make this innovative new oral film product available to
people suffering from migraines,” said Horst G. Zerbe, President
and CEO of IntelGenx. “To that end, we expect to move quickly, with
the objective of resubmitting the RIZAPORT® NDA before the end of
Q3-2019.
IntelGenx continues to look forward to working
with its partner, Gensco® Pharma, to commercialize RIZAPORT® in the
United States upon FDA approval.
About RIZAPORT®:
RIZAPORT® is a patent protected proprietary oral
thin film formulation of rizatriptan benzoate, a 5-HT1 receptor
agonist and the active drug in Merck & Co.'s Maxalt®.
Compared to other triptan-based oral medications, rizatriptan
demonstrates the highest efficacy and exhibits the shortest Tmax
providing quick onset of action for migraine sufferers.
Rizatriptan is considered to be one of the most
effective oral triptans, a class of molecules that constricts blood
vessels in the brain to relieve swelling and other migraine
symptoms. RIZAPORT® is based on IntelGenx’s proprietary VersaFilm™
technology. It dissolves rapidly and releases its active
ingredient in the mouth. The administration method of the
RIZAPORT® oral soluble film, which does not require the patient to
swallow a pill or consume water, along with its neutral flavor,
presents a potentially attractive therapeutic alternative for
migraine patients, specifically for patients who suffer from
migraine-related nausea, estimated to be approximately 80% of the
total migraine patient population and patients suffering from
dysphagia (difficulty swallowing)1.
Reference:
1 Lipton RB, Buse DC, Saiers J, Fanning KM,
Serrano D, Reed ML. (2013) Frequency and burden of headache-related
nausea: results from the American Migraine Prevalence and
Prevention (AMPP) study, Headache. 2013 Jan;53(1):93-103.
About IntelGenx
Established in 2003, IntelGenx is a leading oral
drug delivery company primarily focused on the development and
manufacturing of innovative pharmaceutical oral films based on its
proprietary VersaFilm™ technology platform.
IntelGenx's highly skilled team provides
comprehensive pharmaceuticals services to pharmaceutical partners,
including R&D, analytical method development, clinical
monitoring, IP and regulatory services. IntelGenx's
state-of-the-art manufacturing facility, which was established for
the VersaFilm™ technology platform, offers by supporting lab-scale
to pilot- and commercial-scale production. More information about
the company can be found at www.intelgenx.com.
Forward Looking Statements
This document may contain forward-looking
information about IntelGenx's operating results and business
prospects that involve substantial risks and uncertainties.
Statements that are not purely historical are forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities
Act of 1933, as amended. These statements include, but are not
limited to, statements about IntelGenx's plans, objectives,
expectations, strategies, intentions or other characterizations of
future events or circumstances and are generally identified by the
words "may," "expects," "anticipates," "intends," "plans,"
"believes," "seeks," "estimates," "could," "would," and similar
expressions. All forward looking statements are expressly qualified
in their entirety by this cautionary statement. Because these
forward-looking statements are subject to a number of risks and
uncertainties, IntelGenx's actual results could differ materially
from those expressed or implied by these forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to, those discussed under
the heading "Risk Factors" in IntelGenx's annual report on Form
10-K, filed with the United States Securities and Exchange
Commission and available at www.sec.gov, and also filed with
Canadian securities regulatory authorities at www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Each of the TSX Venture Exchange and OTCQX has
neither approved nor disapproved the contents of this press
release. Neither TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Source: IntelGenx Technologies Corp.
For more information, please contact:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com
Or
Andre Godin, CPA, CA
Executive Vice-President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
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