The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products; Guidance for Industry.” The document provides guidance to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products, including but not limited to those intended for smoking cessation and related chronic indications. This guidance finalizes the draft guidance of the same title issued on February 22, 2019.
**INTRODUCTION **
The purpose of this guidance is to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products, including but not limited to those intended to help cigarette smokers stop smoking cigarettes. As used in this guidance, NRT drug products are nicotine-based drug products intended to help individuals quit smoking cigarettes. Smoking cessation products that do not contain nicotine are not considered NRT drug products. This guidance reflects the FDA’s current recommendations regarding overall development programs to support NRT drug products for smoking cessation and related chronic indications (e.g., reduction in risk of relapse). FDA hosted a public hearing and published a notice in the Federal Register requesting comments on the Agency’s approach to evaluating the safety and effectiveness of NRT drug products, including how the drug products should be used and labeled. This guidance takes into consideration the feedback received and is intended to serve as a focus for continued discussions among the Agency, pharmaceutical sponsors, the academic community, and the public on this topic.
This guidance focuses on drug development and trial design issues that are specific to the study of NRT drug products.
Nonclinical studies are recommended to develop NRT drug products depending on specific aspects of the drug product, such as the route of administration, excipients in the formulation, impurities, and leachables. This guidance does not address recommendations for nonclinical development of NRT drug products. That topic can be addressed through feedback from the relevant FDA review division. Nonclinical development of an NRT drug product with an oral inhalation route of administration is addressed in the guidance for industry Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products (October 2020). Regarding novel excipients in products developed for a different route of administration, refer to principles in the guidance for industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (May 2005).
This guidance does not contain discussion of the general issues of statistical analysis or clinical trial design that are not specific to development of NRT drug products. Those topics are addressed in the International Council for Harmonisation (ICH) guidances for industry E9 Statistical Principles for Clinical Trials (September 1998), E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001), and E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials (May 2021).
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
To continue reading this article please go to US FDA .