FDA to support development of nicotine replacement therapies

The US Food and Drug Administration (FDA) has revealed plans to support the development of new nicotine replacement therapies (NRTs) to help eliminate addiction to combustible cigarettes.

The public health agency aims to also create policies that will regulate the use of nicotine and tobacco in the country with a focus on implementing measures to help existing addicted smokers stop using combustible cigarettes.

Specifically, the FDA will work towards developing new forms of nicotine delivery that are in line with its public health goals.

FDA commissioner Scott Gottlieb said: "Part of this work requires that we recognise that nicotine, while highly addictive, is delivered through products posing a continuum of risk – with combustible cigarettes at one end, to nicotine replacement therapy (NRT) products at the other.

"We’re working on multiple fronts to recognise the role that more novel forms of nicotine delivery could play in achieving our public health goals, as part of an appropriately regulated marketplace."

The FDA’s strategy includes new potentially less harmful tobacco products for adults who still want to use nicotine.

In addition, the regulator will closely monitor the overall approach to developing and regulating nicotine replacement therapies, which are designed in order to safely mitigate withdrawal symptoms.

Gottlieb added: "With novel forms of nicotine delivery being developed, it’s possible that new kinds of NRTs – with different characteristics or routes of delivery – can offer additional opportunities for smokers to quit combustible tobacco."

The FDA has formed a Nicotine Steering Committee to assess new, evidence-based means for enabling use of therapeutic nicotine products against combustible tobacco.

In addition, the agency is considering the types of safety and efficacy studies required, along with the usage and labelling requirements for the new NRT products.

It has released two draft guidances to support the development of inhaled nicotine replacement therapies that could be submitted for approval as new drugs.

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