IntelGenx Corp. (TSX:IGX | OTCQB:IGXT) today announced that its previously undisclosed development candidate, Buprenorphine Buccal Film, for which an abbreviated new drug application (“ANDA”) has been filed by Chemo Research SL (“Chemo”) through its agent and affiliate Xiromed LLC, has received a U.S. Food and Drug Administration Generic Drug User Fee Act (“GDUFA”) date of April 28, 2023.
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, 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.
“We are pleased that our long-term partnership with Xiromed has resulted in this regulatory filing with the FDA, which has indicated that it will complete its review early in the second quarter of next year. Our generic version of Belbuca® is designed to be a bioequivalent, lower-cost alternative for patients. We are looking forward to the FDA’s decision and, assuming a positive outcome, the commercialization of Buprenorphine Buccal Film as soon as possible.”
Dr. Horst G. Zerbe, CEO of IntelGenx
According to IMS Health, a leading healthcare data and analytics provider, global annual sales of Belbuca® amounted to $315 million as of July 2022.
About Xiromed
Xiromed LLC, located in Florham Park, NJ, is the US 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 US, Xiromed has a robust development portfolio of generic pharmaceutical products in various stages of development, including injectable, inhalation and complex generic products.
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.