IntelGenx Provides Regulatory Update for Xiromed-Partnered Development Candidate, Buprenorphine Buccal Film
News provided byIntelGenx Technologies Corp.
Sep 19, 2023, 8:00 AM ET
SAINT LAURENT, Quebec, Sept. 19, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today provided a regulatory update on Buprenorphine Buccal Film, for which an abbreviated new drug application (“ANDA”) has been filed with the U.S. Food and Drug Administration (“FDA” or the “Agency”) by its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”).
As previously announced, Xiromed received a Complete Response Letter (“CRL”) from the FDA in April 2023. In response to the CRL, Xiromed submitted to the FDA an Amendment to the ANDA, requesting priority review. In an Amendment Acknowledgement received from the FDA by Xiromed, the FDA granted priority review with a Generic Drug User Fee Act (“GDUFA”) goal date for review of the Amendment of March 8, 2024, unless the Agency determines that an inspection is required. Alternatively, if the FDA determines that an inspection is required, the GDUFA goal date is July 8, 2024.
“We are pleased with our partner Xiromed’s prompt and fulsome response to the CRL, and are looking forward to the Agency’s decision,” commented Dwight Gorham, IntelGenx’s CEO. “Given the recent pre-approval inspection in March 2023 and subsequent approval of our Rizatriptan oral film, we are optimistic that the FDA will decide to review this Amendment without the need for an additional inspection of our facility.”
About Buprenorphine Buccal Film
Buprenorphine Buccal Film, which incorporates IntelGenx’s VersaFilm® technology in a novel formulation, is a generic version of Belbuca®, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate. Approved by the FDA in 2015, Belbuca® is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 mg to 0.9 mg.
Xiromed LLC, located in Florham Park, NJ, is the U.S. generic division of Insud Pharma, S.L., a global pharmaceutical group headquartered in Madrid, Spain. Xiromed is focused on developing and commercializing high quality generic pharmaceutical products for the US market. In addition to its commercial portfolio of generics available in the U.S., Xiromed has a robust development portfolio of generic pharmaceutical products in various stages of development, including injectable, inhalation and complex generic products. Learn more at http://www.xiromed.com/usa.
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, as well as other CDMO services. 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.
Andre Godin, CPA, CA
President and CFO
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