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SAINT LAURENT, Quebec, April 02, 2019 (GLOBE NEWSWIRE) -- 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.
CONTACT: For more information, please contact: Stephen Kilmer Investor Relations (514) 331-7440 ext 232 This email address is being protected from spambots. You need JavaScript enabled to view it. Or Andre Godin, CPA, CA Executive Vice-President and CFO IntelGenx Corp. (514) 331-7440 ext 203 This email address is being protected from spambots. You need JavaScript enabled to view it.