FDA Grants Cytisinicline Breakthrough Therapy Designation for Vaping Dependence

An announcement was made by pharmaceutical company Achieve Life Sciences, Inc., that the US Food and Drug Administration (FDA) has given the Breakthrough Therapy Designation to plant-based treatment cytisinicline for cessation of nicotine e-cigarettes or vaping.¹

This designation, intended to accelerate the medication’s development and review, was based upon preliminary clinical evidence from the company’s phase 2 ORCA-V1 trial findings published in JAMA Internal Medicine.² The treatment is a partial agonist at α4β2 nicotinic acetylcholine receptors which is designed to mediate nicotine dependence.

“Since there are no FDA-approved medications specifically indicated for nicotine vaping cessation, cytisinicline has the potential to be a first-in-class treatment to address the unique challenges of the over 13 million people in the United States who vape nicotine and are struggling to overcome their addiction,” Cindy Jacobs, MD, PhD, president and chief medical officer of Achieve, said in a statement.

The announcement of the FDA decision noted nicotine e-cigarette use’s rising popularity within the US. The ORCA-V1 trial had been consequently supported by the National Institutes of Health’s National Institute of Drug Abuse.

FDA officials were also noted in the announcement as acknowledging the serious nature of tobacco dependence. They added that longer-term use of vaping has also become known as such given the possible respiratory, cardiovascular, and other risks.

Additionally, concern has been expressed regarding the effect of e-cigarette use among adolescent and young adults in terms of brain development, as well as the higher risk of nicotine addiction noted in ‘The Report of the Surgeon General on E-Cigarette Use Among Youth and Young Adults’.

ORCA-V1 evaluated cytisinicline’s efficacy and safety at a dosage of 3 mg cytisinicline, with administration occurring 3 times-per-day for a total of 12 weeks versus placebo. They looked at 160 adults who had used nicotine e-cigarettes, who did not smoke, and who sought to quit vaping.

The study found that participants treated with cytisinicline were shown to be 2.6 times more likely to quit vaping versus individuals in the placebo arm. The investigators noted a consistent favorable trend for cytisinicline across their secondary endpoints, such as those assessing abstinence during and following treatment, as well as a lack of serious adverse events and excellent rates of compliance.

“Our hope is that with this Breakthrough Therapy Designation and the benefit of increased communication and guidance from the FDA, we can more quickly and efficiently advance cytisinicline as the first approved pharmacotherapy for vaping cessation, not only for adults but potentially in the future for adolescents,” Jacobs concluded in her statement.

References

1. ^{Achieve Life Sciences Announces FDA Grants Breakthrough Therapy Designation to Cytisinicline for the Treatment of E-Cigarette or Vaping Nicotine Dependence. Achieve Life Sciences. July 31, 2024. https://www.globenewswire.com/news-release/2024/07/31/2921816/0/en/Achieve-Life-Sciences-Announces-FDA-Grants-Breakthrough-Therapy-Designation-to-Cytisinicline-for-the-Treatment-of-E-Cigarette-or-Vaping-Nicotine-Dependence.html. Date accessed: July 31, 2024.}
2. ^{Smith T. Cytisinicline, a Plant-Based Medication, Could Help Curb E-Cigarette Use Among Adults Patients. HCPLive. May 6, 2024. https://www.hcplive.com/view/cytisinicline-a-plant-based-medication-could-help-curb-e-cigarette-use-among-adults-patients. Date accessed: July 31, 2024.}