IntelGenx’s (TSX:IGX; OTCQB:IGXT) buprenorphine buccal film – for which an amendment to the abbreviated to new drug application (ANDA) requesting priority review has been filed by Chemo Research through its agent and affiliate, Xiromed – has received an FDA generic drug user fee act (GDUFA) date of March 8, 2023, unless the FDA determines an inspection is required.
If the FDA determines that an inspection is required, the GDUFA goal date is July 8, 2024.
Buprenorphine buccal film is a generic version of Belbuca, an opioid that is used to manage 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.
IntelGenx partnered with Chemo Research, part of the Insud Pharma Group, on the development of buprenorphine buccal film in September 2016. Buprenorphine buccal film incorporates IntelGenx’s VersaFilm technology in a novel formulation. The companies co-developed the candidate’s ANDA that is currently under review by the FDA.
Xiromed is the U.S. generic division of Insud Pharma, a global pharmaceutical group headquartered in Madrid, Spain.
“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,” Dwight Gorham, CEO of IntelGenx, said in a statement.
