The US Food and Drug Administration on Friday issued a draft guidance to help ‘lay out a framework for new potential clinically relevant outcomes for smoking cessation products, such as reducing the chance of a smoker going back to using cigarettes long term’.
‘This draft guidance takes into consideration the input received at the public hearing in January 2018 and is intended to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the cessation research community, and the public,’ the FDA Commissioner Scott Gottlieb, M.D., said in a statement posted on the agency’s website.
‘The aim of the guidance is to describe new endpoints that are meaningful to helping currently addicted adult smokers, and that can promote innovation in NRT by outlining a broader set of criteria that can serve as the basis for new approvals.’
The draft guidance, Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products, follows the issue of the FDA’s first guidance in August 2018: Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.
The Gottlieb statement ends with: ‘As we look toward the future and the possibility of a world where combustible cigarettes could no longer create or sustain addiction, these guidances are part of comprehensive steps to pave the way for new, safe and effective products that can help currently addicted smokers quit the deadliest form of nicotine delivery.’