IntelGenx Announces Receipt of Complete Response Letter from the FDA for Xiromed-Partnered Buprenorphine Buccal Film
IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) announced a Complete Response Letter (CRL) from the U.S. FDA pertaining to its abbreviated new drug application for Buprenorphine Buccal Film.
The letter was issued to their partner Xiromed LLC, with plans to address the FDA's concerns in the current quarter.
This generic version of Belbuca, approved in 2015, aims to manage chronic pain. The company is evaluating options for reconsideration of the CRL. IntelGenx is focused on drug delivery technologies, enhancing pharmaceutical options.
- Expected response to CRL in the current quarter.
- Xiromed plans to address FDA concerns promptly.
- Received a Complete Response Letter from the FDA.
- Concerns from the FDA could delay product launch.
CRL response expected in current quarter
SAINT LAURENT, Quebec, April 27, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the submitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film. Xiromed and IntelGenx will contact FDA to discuss the CRL and assess the filing of a request for reconsideration of the CRL.
Andre Godin, IntelGenx’s President and CFO, commented, “Our partner Xiromed has relayed to us that they plan to promptly address the FDA’s concerns in the current quarter.”
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.
About Xiromed
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.
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
FAQ
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