The smoking cessation drug candidate cytisinicline significantly improved smoking quit rates compared to placebo in adults with and without COPD.
RT’s Three Key Takeaways:
- Cytisinicline Boosts Quit Rates — New Thorax data show cytisinicline significantly improves smoking cessation in adults with and without COPD, even among those with heavy nicotine dependence.
- Safe and Well-Tolerated — The investigational therapy demonstrated a favorable safety profile, with no serious treatment-related adverse events and low rates of common side effects across subgroups.
- High Impact for COPD Patients — With nearly 80% of COPD deaths linked to smoking, cytisinicline could become a vital new FDA-approved tool (decision expected June 2026) for millions seeking to quit.
New data in Thorax demonstrates that cytisinicline significantly improved smoking quit rates compared to placebo in adults with and without COPD, according to Achieve Life Sciences Inc.
The research builds on data from over 1,600 participants in two large, randomized, placebo-controlled Phase 3 trials (ORCA-2 and ORCA-3). In this newly published post hoc analysis, researchers evaluated the efficacy and safety of cytisinicline in the subgroup of participants with self-reported COPD, a population at high risk from continued smoking and for whom effective, well-tolerated cessation therapies are urgently needed.
Cytisinicline is a plant-derived alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed as a treatment of nicotine dependence for smoking cessation and has not been approved by the Food and Drug Administration for any indication in the United States. Cytisinicline has been granted Breakthrough Therapy designation by the FDA, according to Achieve Life Sciences.
Dr. Judith Prochaska, lead author and Professor of Medicine at Stanford University, said, “COPD patients in our study smoked for many years and had high levels of nicotine addiction. Importantly, we found that cytisinicline significantly increased the odds of quitting for this high-risk group, with an excellent tolerability profile. If approved, cytisinicline would be a new treatment tool for providers in improving health outcomes for millions living with COPD.”
Cytisinicline was associated with robust and statistically significant increases in continuous smoking abstinence compared to placebo for both COPD and non-COPD subgroups. Despite having more severe tobacco use histories and greater prior prescription treatment exposure, participants with COPD achieved quit rates with cytisinicline comparable to those without COPD, supporting cytisinicline as a potential new pharmacologic option for people with COPD who smoke. Importantly, cytisinicline demonstrated a favorable safety profile in both COPD and non-COPD subgroups, with no serious treatment-related adverse events and low rates of common side effects.
“These data highlight the meaningful addition cytisinicline could make for COPD patients who are seeking a safe and effective way to quit smoking,” added Dr. Mark Rubinstein, study co-author and Head of Medical Affairs at Achieve. “For physicians, these results provide much-needed evidence supporting a well-tolerated potential new treatment option for a specific sub-population that traditionally faces significant barriers to successful smoking cessation. This publication reinforces Achieve’s commitment to improving outcomes for patients and empowering healthcare providers with new tools in the fight against nicotine dependence.”
According to the CDC, nearly 16 million US adults reported that they have been diagnosed with COPD. Among those diagnosed with COPD, six million reported they currently smoke cigarettes. Given that almost 80% of COPD deaths are attributed to smoking, quitting is the most effective way to prevent and improve outcomes in smokers with COPD.
Achieve recently announced that the FDA accepted its cytisinicline New Drug Application for treatment of nicotine dependence for smoking cessation, with a PDUFA target action date of June 20, 2026. Additionally, the company has completed a Phase 2 trial with cytisinicline in vaping cessation.
