The Food and Drug Administration (FDA) is announcing the comment period for a draft guidance for industry entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy [NRT] Drug Products.” This draft guidance reflects the FDA's current recommendations regarding overall development programs to support the approval of NRT drug products for smoking cessation and related chronic indications.
There are several FDA-approved prescription and nonprescription NRT drug products for cessation of smoking cigarettes, but the Agency encourages the development of additional NRT drug products, which could help more smokers quit. In November 2017, FDA published a notice in the Federal Register requesting comments on the Agency's approach to evaluating the safety and efficacy of NRT drug products, including how they should be used and labeled (82 FR 56759; Docket No. FDA-2017-N-6529). The Agency hosted a public hearing in January 2018 to obtain input from stakeholders on these issues. This draft guidance takes into consideration the feedback received and is intended to serve as a focus for continued discussions among the Agency, pharmaceutical sponsors, the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.
The draft guidance focuses on drug development and trial design issues that are specific to the study of NRT drug products. NRT drug products are typically studied and labeled for use as adjuncts to behavioral self-help materials and to date have involved single treatment regimens that begin on the patient's quit day. Alternate treatment regimens (e.g., pretreatment before quit day, quitting by gradual reduction (reduce to quit), using multiple NRT drug products together) are discussed in the guidance.
As outlined in the guidance, NRT drug products can be developed for smoking cessation and/or reduction in risk of relapse. NRT drug products that first have demonstrated efficacy for at least one of these indications can also include additional information in labeling by demonstrating efficacy in certain secondary endpoints. Sponsors can evaluate reduction in the urge to smoke or relief of cue-induced craving in former smokers, as secondary endpoints. Additionally, sponsors that can demonstrate, via a secondary endpoint, that the drug product provides relief of withdrawal symptoms in smokers who are not trying to quit smoking, may be able to include labeling instructions to address situations when such individuals are required to abstain and therefore experience withdrawal symptoms (e.g., while traveling on an airplane).
FDA is aware of the serious risks associated with smoking and is committed to facilitating the development of therapies to support smoking cessation efforts. Both the regulatory pathway for an NRT drug product and the amount of nonclinical or clinical data needed to support approval will depend on the characteristics of the proposed NRT drug product relative to an approved NRT drug product. This guidance outlines general considerations for NRT drug development and trial design, and FDA encourages sponsors to contact FDA for feedback on their proposed development plans. Sponsors developing an over-the-counter drug product should bear in mind that it is often not possible to answer all regulatory questions in a single trial, and additional sequential steps may be needed.
Comments on this draft guidance may be submitted electronically, through this portal on Regulations.gov, or through mail in written form. For more information regarding this draft guidance and the comment submission process, please see this Federal Register notice.