08:10 AM EDT, 04/05/2024 (MT Newswires) -- IntelGenx Corp. (IGX.TO) on Friday said its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC, has received a Complete Response Letter (CRL) from the 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 ( IGXT ) facility is required at this time.

Buprenorphine Buccal Film, which incorporates IntelGenx's ( IGXT ) 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.