Guide on Developing Nicotine Replacement Drug Products

FDA has released a draft guidance on “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy (NRT) Drug Products.” The document reflects the agency’s current recommendations on overall development programs to support NRT drug products for smoking cessation and related chronic indications. It focuses on drug development and trial design issues that are specific to the study of NRT drug products. “Nonclinical studies can be needed to develop NRT drug products depending on specific aspects of the drug product, such as the route of administration, and the dose of excipients and impurities, including extractables and leachables,” the agency says. The guidance does not address recommendations for nonclinical development, nor general issues of statistical analysis or clinical trial design that are not specific to development of NRT drug products.