Canadian Company's New Version Of Chemo-Induced Pain Treatment Is On FDA Track

Drug delivery company IntelGenx Corp. IGXT’s development candidate buprenorphine buccal film, for which an Abbreviated New Drug Application (ANDA) has been filed by Chemo Research SL through its agent and affiliate generic pharma products company Xiromed LLC (the US division of Insud Pharma SL) received an FDA Generic Drug User Fee Act (GDUFA) dated April 28, 2023.

According to FDA’s page, the Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry, with the ultimate goal of ensuring patients’ access to “safe, high-quality, and affordable generic drugs.”

This law requires the industry to pay user fees to meet the costs of reviewing generic drug applications and inspecting facilities in a timely manner. As IntelGenx’s filed ANDA received a final review date for 2023, if the outcome is positive, the company would soon after be allowed to begin commercializing its generic drug. 

Dr. Horst G. Zerbe, CEO of IntelGenx said the company is pleased that its long-term partnership with Xiromed resulted in the FDA regulatory filing indicating 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,” explained the CEO.

Belbuca, first approved by the FDA in 2015, 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.

As its predecessor, the generic buprenorphine buccal film is designed as an opioid to manage severe pain requiring daily, long-term treatment where other pain treatments are inadequate. Its development, which began in September 2016, incorporates IntelGenx’s versafilm technology in a new formulation developed by both IntelGenx and Chemo. 

More broadly speaking, IntelGenx’s film technologies partner with and support next-gen medicines addressing unmet medical conditions, such as the polymeric buccal film containing a synthetic DMT-like drug recently developed for psychedelics company atai ATAI.

Photo by Hans Reniers on Unsplash