The FDA is accelerating the evaluation process for cytisinicline as a nicotine withdrawal aid.

The U.S. Food and Drug Administration (FDA) has announced the selection of nine drugs under its new Commissioner's National Priority Voucher (CNPV) pilot program, designed to expedite the review of drugs and biologics that address critical national public health challenges. Among these drugs is cytisinicline, Achieve's lead drug, developed for smoking cessation.[1]Thanks to this priority status, the review process could be reduced to 1 to 2 months, compared to the usual 10 to 12 months. Meanwhile, the FDA has accepted the Non-Discharge Approval (NDA) application for cytisinicline for vaping cessation in adults, with a decision expected in June 2026. If approved, it would be the first new treatment for nicotine addiction in nearly 20 years.

Cytisinicline, a promising treatment for nicotine addiction

Cytisinicline or cytisine is a plant-based drug that acts on nicotinic receptors, similarly to Champix (varenicline or Chantix in the United States), but with fewer side effects, including less nausea and vomiting, which often lead to discontinuation of treatment.

Achieve Life Sciences is studying the benefits of its drug in specific high-needs populations: in September, Achieve announced a new analysis published in Thorax showing that cytisinicline significantly improved smoking cessation rates in smokers with chronic obstructive pulmonary disease (COPD), given that nearly 80% of COPD deaths are attributable to smoking.[2].

Smokers with COPD often have more difficulty quitting, frequently having a longer history of smoking, increased nicotine dependence, and co-occurring depression. Data pooled from 1,600 participants in the ORCA-2 and ORCA-3 trials indicated that cytisinicline was effective in both smokers with and without COPD. This suggests the drug could fill a critical therapeutic gap for the millions of smokers with lung disease.

In addition, the FDA also granted cytisinicline "breakthrough therapy" designation for vaping cessation in July 2025 and approved the design of the phase 3 trial that would support an additional new drug application for this indication, a first in its class, with a target action date set for June 20, 2026.

According to the FDA, this approach addresses a growing public health need: 17 million American adults use e-cigarettes, 60 million of whom want to quit, but no approved treatment currently exists. Phase 2 clinical trials showed that participants treated with cytisinicline were 2.6 times more likely to stop using nicotine e-cigarettes compared to those receiving a placebo.

Thanks to its proven efficacy and favorable tolerability profile, cytisinicline could become a standard treatment for reducing nicotine addiction, whether from tobacco or vaping. It is also recognized by the WHO, which has placed it on its Model List of Essential Medicines (EML).officially recognizing its strategic role in the fight against smoking alongside nicotine replacement therapies, bupropion and varenicline, expanding the range of validated and accessible therapies.

While the current focus is on traditional and e-cigarettes, Achieve's cytisinicline could be applied to other forms of nicotine addiction, such as chewing tobacco, in the future. The company has not yet announced any specific trials in these areas, but its broader mission is to address the "global nicotine epidemic."

A possible major breakthrough in the fight against nicotine addiction

If cytisinicline receives approval in 2026, it will become the first drug approved since 2006 for smoking cessation and the first specifically designed to stop vaping. Projections anticipate a potential launch in 2027, with a 60% probability of success for the vaping-related indication.

However, some experts point out that the company remains vulnerable to the regulatory uncertainties inherent in the biotechnology sector. Furthermore, FDA scientists retain the authority to extend the review period if an application is incomplete, if manufacturing violations are found, or if further evaluation is deemed necessary.[3].

This dual stance, against addiction to tobacco products and vaping, could mark an important step in the fight against nicotine addiction, a public health issue given that approximately 29 million adults in the United States smoke combustible cigarettes and that, according to federal data, approximately 1.6 million American middle and high school students reported using e-cigarettes in 2024.[4]More than 87% of lung cancer deaths, 61% of all deaths from respiratory disease, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.[5].

Despite remaining uncertainties, Achieve Life Sciences is now establishing itself as a key player in a sector that has long been neglected. Its potential success could not only transform its financial future but also usher in a new era in the treatment of tobacco and nicotine addiction.

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[1]Mateusz Kaczmarek, Achieve Life Sciences Skyrockets on FDA Boost – Is This Nicotine Addiction Breakthrough a Game Changer?TechStock², published October 17, 2025, accessed October 22, 2025

[2]Prochaska J, Rubinstein M, Perdok R, et al, Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trialsThorax, published on September 17, 2025, accessed on October 22, 2025

[3]2firsts, US FDA Includes Cytisinicline for Vaping Addiction in National Priority Voucher Program, Shortens Review to 1–2 MonthsPublished on October 20, 2025, accessed on October 22, 2025

[4]Investing.com, FDA grants priority voucher for cytisinicline as vaping cessation aidPublished on October 17, 2025, accessed on October 22, 2025

[5]GlobeNewswire, Achieve Life Sciences Receives FDA Commissioner's National Priority Voucher for Cytisinicline for Treatment of Nicotine Dependence for E-cigarette or Vaping CessationPublished on October 17, 2025, accessed on October 22, 2025

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