Incannex Healthcare Inc (NASDAQ:IXHL) has welcomed feedback from the US Federal Drug Administration in a pre-investigational new drug (IND) meeting concerning the development of CannQuit-N, a treatment designed to help patients quit smoking tobacco and control relapses.
The FDA provided several recommendations on key design aspects of the proposed clinical trials for CannQuit-N, including the timing of efficacy endpoints and specific details on safety endpoints.
The FDA also confirmed IXHL’s proposed strategies for manufacturing and quality control are appropriate.
The successful meeting marks an important milestone in the development of CannQuit-N, plotting a pathway to continued development of the product within the FDA’s framework.
Cannabis-based chewing gum
CannQuit-N is a chewing gum designed to aid in the cessation of tobacco smoking through the controlled release of cannabidiol (CBD), one of the main active compounds in cannabis, and nicotine.
CBD has been found to inhibit the α7 nicotinic acetylcholine receptor which plays a role in the reinforcing effects of nicotine.
For this reason, the combination of CBD and nicotine may better assist smokers in quitting their tobacco consumption compared to nicotine alone.
Smoking tobacco is responsible for more than 480,000 deaths per year in the US alone, including 42,000 from second-hand smoke exposure.
The total economic cost of smoking in the US is estimated to be more than US$300 billion per year.
This includes nearly US$225 billion in direct medical care for adults and more than $156 billion in lost productivity.