IntelGenx Announces FDA’s Acceptance of Resubmission of New Drug Application for RIZAPORT®
November 20 2018 - 8:00AM
- PDUFA Goal Date of April 1, 2019
-
IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT) (the “Company” or
“IntelGenx”) today announced that its 505(b)(2) New Drug
Application (“NDA”) resubmission for RIZAPORT® oral soluble film 10
mg for the treatment of acute migraines has been accepted for
review by the U.S. Food and Drug Administration (“FDA”). The
FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) goal
date for completion of the review of the RIZAPORT® NDA of April 1,
2019.
“We are pleased that the FDA has accepted for
review the resubmission of the NDA for RIZAPORT®, and will be
working with the Agency to achieve our goal of offering the first
oral thin film on the market for the treatment of migraines,“ said
Dr. Horst Zerbe, CEO of IntelGenx.
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®.
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, leading to efficient absorption of the
drug through the gastrointestinal tract. 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, established for the
VersaFilm™ technology platform, supports lab-scale to pilot and
commercial-scale production, offering full service capabilities to
its clients. 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 KilmerInvestor Relations (514) 331-7440 ext
232stephen@intelgenx.com
Or
Andre Godin, CPA, CAExecutive Vice-President and CFOIntelGenx
Corp.(514) 331-7440 ext 203andre@intelgenx.com
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