FDA Issues Guidance for Developers of Nicotine Replacement Drugs

The FDA released draft guidance on drug development and trial design for nicotine replacement therapy (NRT) drugs.

The agency defines the primary efficacy endpoint for a smoking cessation trial as “the proportion of subjects who are abstinent from cigarette use over the entire efficacy ascertainment period,” which should be at least four weeks.

FDA Commissioner Scott Gottlieb said the agency’s aim in the guidance is to “promote innovation in NRT by outlining a broader set of criteria that can serve as the basis for new approvals.”