IntelGenx Updates Status of Buprenorphine Buccal Film ANDA

Rhea-AI Summary

IntelGenx Corp. (IGXT) receives a Complete Response Letter from the FDA for Buprenorphine Buccal Film, requiring additional Pharmaceutical Quality information. The FDA confirms no further facility inspection needed. The drug is a generic version of Belbuca®, used for chronic pain management.

Positive

• None.

Negative

• The Complete Response Letter (CRL) from the FDA indicates a delay in the approval process for Buprenorphine Buccal Film, potentially impacting revenue generation.
• The request for additional Pharmaceutical Quality information suggests potential quality control issues that need to be addressed, which could lead to further delays in the approval process.
• The commitment to providing a response to the CRL 'as soon as is practicable' does not provide a clear timeline for resolution, leaving uncertainty regarding the next steps in the approval process.

SAINT LAURENT, Quebec, April 05, 2024 (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 its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.

The CRL includes a request for additional Pharmaceutical Quality information. The FDA confirmed that no additional inspection of IntelGenx’s facility is required at this time.

“Our partner is committed to providing the FDA with a response to the CRL as soon as is practicable,” commented Dwight Gorham, IntelGenx’s CEO.

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 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 SEC and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedarplus.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

What is the ticker symbol for IntelGenx Corp.?

The ticker symbol for IntelGenx Corp. is IGX.

What type of letter did IntelGenx Corp. receive from the FDA regarding Buprenorphine Buccal Film?

IntelGenx Corp. received a Complete Response Letter (CRL) from the FDA.

What information is the FDA requesting in the Complete Response Letter (CRL) for Buprenorphine Buccal Film?

The FDA is requesting additional Pharmaceutical Quality information in the CRL.

What is the drug Buprenorphine Buccal Film used for?

Buprenorphine Buccal Film is used for managing chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid.

When was Belbuca® approved by the FDA?

Belbuca® was approved by the FDA in 2015.

What technology does IntelGenx's VersaFilm® incorporate in Buprenorphine Buccal Film?

IntelGenx's VersaFilm® technology is incorporated in the novel formulation of Buprenorphine Buccal Film.