FDA Lays Out Efficacy Endpoints, Abbreviated Pathways For NRT Drugs

FDA on Friday (April 28) finalized wide-ranging guidance for developing nicotine replacement therapy drug products intended to help cigarette smokers stop smoking, establishing efficacy endpoints and recommending abbreviated pathways for drug sponsors. The guidance says drug makers can factor reductions in risk of relapse when measuring their drug products’ effectiveness. In addition to recommendations for efficacy studies, the guidance also lays out parameters for nonprescription labeling and consumer behavior studies. It also includes considerations for studies in pediatric populations. FDA...