By Angela Garrity 

The FDA announced additional draft guidance steps by the agency to support the development of safe and effective novel nicotine replacement therapies (NRT) in an effort to ‘help smokers quit’. Part of this plan appears to include a two-leg approach – Developing NRT Drug Products and Nonclinical Testing of Orally Inhaled Nicotine Containing Drug Products. Neither of these steps are effective at this time and are listed for comment purposes only.

 

In a statement released by the FDA, the message specifically around vaping is:

 

“Novel products with different characteristics or routes of nicotine delivery have the potential to offer additional opportunities for health-concerned smokers interested in quitting. This could also include products such as electronic nicotine delivery systems like electronic cigarettes, but which would need to be proven safe and effective for smoking cessation and regulated as a drug product. This would allow them to be marketed as a prescription or over-the-counter drug products with medical claims for smoking cessation or related indications – ultimately reducing the likelihood of someone continuing to suffer the clinical consequences of smoking. This is different from our regulation of e-cigarettes as tobacco products.”

 

This guidance document is dated August 2018.

 

The FDA goes on to describe their Nicotine Steering Committee on:

 

“creating a more flexible framework that enables the development of safe and effective product innovations that have the potential to help smokers quit combustible cigarettes and improve their health. This included holding a public hearing in January 2018 examining the types of safety and efficacy studies we suggest be conducted and the way these products are used and labeled and developing guidance to facilitate the development of these products.”

 

The FDA adds,

 

“Building on these efforts to encourage innovation of drug products to help more smokers quit cigarettes, today, we’re releasing the second of two draft guidances aimed at supporting the development of novel nicotine replacement therapies that could be sold as new FDA-approved drugs, similar to current prescription and over-the-counter NRT drug products.”

 

The draft guidance issued today that is being referenced in this statement is entitled “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products”. In the agency’s own words:

 

“This draft guidance takes into consideration the input received at the public hearing in January 2018 and is intended to serve as a focus for continued discussions among the FDA,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 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.”

 

This document is dated February 2019.