New steps FDA is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes - Drug Information Update

FDA has released the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies (NRTs) that could be submitted to the FDA for approval as new drugs, similar to current over-the-counter pharmaceutical NRT products. The guidance, “Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products,” focuses on data recommended to evaluate potential toxicities associated with orally inhaled nicotine-containing drug products. This includes products such as electronic nicotine delivery systems like e-cigarettes that are intended for smoking cessation and other long-term uses that would make them subject to regulation as drugs.   FDA anticipates releasing the second draft guidance this fall that will help lay out a framework for new potential clinically relevant outcomes for smoking cessation products. These guidances are one part of larger policy efforts to address the public health crisis of tobacco usage in this country. Given some of these products are relatively new technologies, or innovations that haven’t yet been through the product development and evaluation process, we’ll be seeking input on these draft guidances and welcome feedback on whether we’ve struck the right balance between innovation and safety; and set the right framework to encourage companies to use the new drug pathway to bring novel NRT products to market, with our public health mission leading the charge. For more information, please visit: FDA Commissioner Scott Gottlieb, M.D.’s statement on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes.