FDA is taking steps support the development of novel nicotine replacement drug therapies
In a statement, FDA Commissioner Scott Gottlieb discusses the agency's efforts to recognize the role that more novel forms of nicotine delivery could play in achieving public health goals.
In a statement, FDA Commissioner Scott Gottlieb discusses the agency's efforts to recognize the role that more novel forms of nicotine delivery could play in achieving public health goals. "Part of this work requires that we recognize that nicotine, while highly addictive, is delivered through products posing a continuum of risk—with combustible cigarettes at one end, [and] nicotine replacement therapy (NRT) products at the other," he explains. Gottlieb adds, "The development of novel NRT products, regulated as new drugs, is a critical part of our overall strategy on nicotine." Most existing NRTs—including gums and patches—have been approved for more than 2 decades. However, new types of NRTs—with different characteristics or routes of delivery—may offer additional ways for smokers to stop using combustible tobacco. FDA released Friday the first of two draft guidances aimed at supporting the development of novel, inhaled NRTs that could be submitted to FDA for approval as new drugs, similar to current OTC pharmaceutical NRT products. The draft guidance includes data recommended to evaluate potential toxicities linked to orally inhaled nicotine-containing drug products. The second draft guidance, which will help lay out a framework for new potential clinically relevant outcomes for smoking cessation products, is expected to be released this fall.