Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products (Draft Guidance for Industry)

Policy Details

Policy Details

Last Action
Guidance Issued
Date of Last Action
Feb 21 2019
Date Introduced
Feb 21 2019
Publication Date
Feb 22 2019

SciPol Summary

The Food and Drug Administration (FDA) issued a draft guidance for industry, “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products,” to assist industry professionals with drug development and trial design considerations for the study of nicotine replacement therapy (NRT) drug products. The Centers for Disease Control and Prevention states that NRT drugs are the most common medications used by individuals to quit smoking, and, according to the FDA, often consist of a single treatment regimen on an individual’s quit day (i.e., day that they commit to stop smoking). This guidance is focused on the clinical development of NRT; information on the nonclinical development of NRT drugs can be found in a separate guidance, “Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.”  

Currently, all FDA-authorized NRT drugs products are approved for the cessation of cigarette smoking. Drugs are considered significantly different from these approved NRT drugs, and therefore require a different regulatory pathway, in the case of a new route of administration or a new indication. As part of the development program for NRT drugs, a new drug application (NDA) is required as specified in the Federal Food, Drug, and Cosmetic Act (FD&C Act). For NRT drugs that are similar to the previously-approved drugs, only an abbreviated new drug application is required as specified under the FD&C Act. The guidance further outlines considerations for studies to conduct depending on how closely the newly developed NRT drug resembles a previously-approved NRT drug.

Various other considerations for the development of NRT drug products are also mentioned. The general considerations for early phase clinical development aim to determine drug activity across a range of nicotine doses. Factors to consider for efficacy trials (i.e., looking at the benefits and harms of interventions under controlled conditions) include trial design and endpoints assessment. One of the main endpoints is measuring abstinence which the guidance defines as “no cigarette use over the entire course of the efficacy ascertainment period by subject self-report and biological verification at intervals of approximately 1 to 2 weeks.” Finally, considerations regarding pediatric populations, behavioral counseling, statistical considerations, and the clinical benefits of smoking cessation are also presented. All these considerations are aimed to help develop effective NRT drug products.

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