IntelGenx Submits Response to CRL from FDA for RIZAPORT® VersaFilm®
IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) has officially responded to the Complete Response Letter (CRL) from the FDA regarding its New Drug Application for RIZAPORT® VersaFilm®, originally received in March 2020. The company is optimistic following discussions with the FDA, believing that their submission addresses all required additional Chemistry, Manufacturing, and Controls information. IntelGenx aims to provide this medication for acute migraine patients in collaboration with the FDA.
- Successful response to FDA's Complete Response Letter regarding RIZAPORT® VersaFilm®.
- Positive interactions with the FDA indicating potential progress in approval.
- Conducted additional testing to meet FDA requirements.
- Initial CRL received in March 2020 indicating prior concerns from the FDA.
- Uncertainty remains until FDA's final decision on the NDA.
SAINT LAURENT, Quebec, Oct. 18, 2022 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced that it has responded to the Complete Response Letter (“CRL”) for its 505(b)(2) New Drug Application (NDA) for RIZAPORT® VersaFilm® received from the U.S. Food and Drug Administration (“FDA”) in March 2020.
“We have been encouraged by our interactions with the FDA and are pleased to submit our response to the CRL,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “Based on the feedback from our Type A meeting, we conducted additional product testing and believe that this response provides all of the additional Chemistry, Manufacturing and Controls information that the FDA required. We are looking forward to continuing to work with the Agency to make RIZAPORT® VersaFilm® available to acute migraine patients.”
About IntelGenx
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.
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 offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.
Forward-Looking Information and 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.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
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