MELBOURNE – Incannex Healthcare Inc. (NASDAQ:IXHL), a biotech company specializing in cannabinoid and psychedelic medicine, has reported a key development in its drug program following a pre-IND meeting with the U.S. Food and Drug Administration (FDA). The discussion, which took place earlier this week, focused on CannQuit-N, the company's investigational chewing gum designed to help individuals quit smoking tobacco.
During the teleconference, the FDA reviewed Incannex's proposed strategies for the clinical trials of CannQuit-N, offering guidance on the design, including efficacy and safety endpoints. The agency also approved the company's manufacturing and quality control plans for the drug.
CannQuit-N combines cannabidiol (CBD) with nicotine in a controlled-release chewing gum format. Incannex holds patents for this combination, which is believed to be potentially more effective for smoking cessation than traditional nicotine replacement therapies (NRTs). The global NRT market, valued at $2.92B in 2021, is projected to grow to $7.93B by 2029.
The product's development is significant given the high cost of smoking-related illnesses in the U.S., which includes over 480,000 deaths annually and an economic impact exceeding $300B. Incannex's approach leverages the oral mucosa's circulation for rapid and sustained delivery of active ingredients, aiming to reduce cravings more effectively.
Incannex is a clinical stage pharmaceutical company pursuing FDA approval for a range of treatments targeting conditions with limited existing pharmacotherapy options. The company holds 19 granted patents and has 30 pending applications.
This announcement, confirming the progress of CannQuit-N, was authorized for release by Incannex's Board of Directors and is based on a press release statement. The company's forward-looking statements are subject to change, and it assumes no obligation to update or revise them as new information becomes available.
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