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IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) announced a Complete Response Letter (CRL) from the U.S. FDA pertaining to its abbreviated new drug application for Buprenorphine Buccal Film.
The letter was issued to their partner Xiromed LLC, with plans to address the FDA's concerns in the current quarter.
This generic version of Belbuca, approved in 2015, aims to manage chronic pain. The company is evaluating options for reconsideration of the CRL. IntelGenx is focused on drug delivery technologies, enhancing pharmaceutical options.
IntelGenx Corp. announced FDA approval for its migraine treatment, RIZAFILM®, which will be the first oral thin film available in the U.S. for acute migraines. The product, a proprietary formulation of rizatriptan benzoate, addresses a significant market need, as approximately 39 million Americans suffer from migraines. The global migraine medication market is projected to grow from $3 billion in 2021 to nearly $11 billion by 2030, with a compound annual growth rate of 15.6%. IntelGenx has partnered with Gensco® Pharma for the commercialization of RIZAFILM®, benefiting from royalty payments based on net profits and milestone payments. Following a successful FDA inspection of its manufacturing facility, IntelGenx is well-positioned to meet market demands for rapid, effective migraine relief.