FDA Drafts Guidance for Nicotine-Containing Smoking Cessation Drugs

The FDA unveiled new draft guidance Monday on nonclinical testing of orally-inhaled drug products that contain nicotine — and Commissioner Scott Gottlieb said the agency plans to release follow-up guidelines later this year on potentially clinically relevant outcomes.

The majority of smoking cessation products that use nicotine replacement therapy were approved at least 20 years ago. As more novel forms become available, Gottlieb said the FDA is re-assessing how to create a regulatory environment that enables innovation.

For a nonclinical toxicity assessment, the agency recommends that sponsors submit toxicity information for all components of the drug product formulation, heat-generated products and impurities.