02:20:15 EDT Tue 30 Apr 2024
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IntelGenx Technologies Corp
Symbol IGX
Shares Issued 174,658,096
Close 2024-04-04 C$ 0.26
Market Cap C$ 45,411,105
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IntelGenx partner Chemo receives FDA response letter

2024-04-05 10:18 ET - News Release

Mr. Dwight Gorham reports

INTELGENX UPDATES STATUS OF BUPRENORPHINE BUCCAL FILM ANDA

IntelGenx Corp.'s co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC, 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 chief executive officer. 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 milligram to 0.9 milligram.

About IntelGenx Corp.

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 research and development, analytical method development, clinical monitoring, intellectual property, and regulatory services. IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production.

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