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Nonclinical Testing of Nicotine Products: FDA Drafts Guidance

Posted 03 August 2018 | By Zachary Brennan 

Nonclinical Testing of Nicotine Products: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Friday drafted new guidance to offer recommendations on the nonclinical information necessary to support the development and approval of orally inhaled nicotine-containing drug products intended for smoking cessation.

The 12-page draft focuses on novel components of the drug formulation, novel chemicals generated from any component of the formulation by the delivery system, and novel impurities from the drug formulation and delivery system.

“An adequate nonclinical assessment can address the potential toxicity of chemicals from orally inhaled nicotine-containing drug products,” the draft says. “Some of these products have already been associated with toxicity concerns.”

The draft also focuses on different types of toxicology studies, including developmental and reproductive toxicology and genetic toxicology.

FDA Commissioner Scott Gottlieb said in a statement: “We want to strike the right balance between enabling a viable, efficient path for these products to be regulated as drugs – where we have substantial tools to evaluate their safety and efficacy for their intended use as smoking cessation products.”

A second draft guidance is coming out this fall, Gottlieb noted, to help lay out a framework for new potential clinically relevant outcomes for smoking cessation products, such as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 and showing a positive impact on certain measures of cardiovascular health.

“That future guidance also is expected to address potential alternative treatment regimens like pre-treatment before quit day, quitting by gradual reduction (reduce-to-quit), or using two NRT [nicotine replacement therapy] drug products together,” he said.

Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products: Draft Guidance for Industry

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