TOPLINE:

Treatment with cytisinicline was effective for smoking cessation in both people with chronic obstructive pulmonary disease (COPD) and those without COPD, offering hope for people who face greater challenges in quitting smoking.

METHODOLOGY:

• Researchers conducted a post hoc analysis of combined data from two phase 3 trials (ORCA-2 and ORCA-3) to assess the efficacy and safety of cytisinicline for smoking cessation, especially in participants with COPD.
• They included 1602 adults (mean age, 52.2 years; 55% women) from multiple sites in the US who smoked ≥ 10 cigarettes per day, had expired air carbon monoxide ≥ 10 ppm, and agreed to quit smoking. Among them, 145 self-reported COPD.
• Participants were randomly assigned to receive either 3 mg cytisinicline three times daily for 12 weeks, 3 mg cytisinicline three times daily for 6 weeks followed by placebo three times daily for 6 weeks, or placebo three times daily for 12 weeks.
• Participants also received up to 14 trained counselor-led, 10-minute behavioral support sessions from before randomization to week 12, with follow-up sessions at weeks 16, 20, and 24.
• The primary endpoint was biochemically confirmed continuous smoking abstinence during the last 4 weeks of treatment (weeks 3-6 for the 6-week regimen and weeks 9-12 for the 12-week regimen).

TAKEAWAY:

• Participants with COPD were older, had longer smoking histories, greater nicotine dependence, and higher levels of depression than those without COPD.
• After 6 weeks, cytisinicline treatment led to significantly higher abstinence rates than placebo in participants with COPD (17.3% vs 2.1%; P = .03) and in those without COPD (19.3% vs 5.5%; P < .0001).
• Similarly, after 12 weeks, cytisinicline treatment yielded higher abstinence rates than placebo in participants with COPD (19.1% vs 4.3%; P = .04) and in those without COPD (32.6% vs 8.6%; P < .0001).
• Rates of treatment-emergent adverse events were similar across all treatment groups.

IN PRACTICE:

“Findings indicate that cytisinicline may be an efficacious and well-tolerated treatment for those with COPD who smoke, offering a new option for a large patient group that often faces unique barriers to smoking cessation,” the authors of the study wrote.

SOURCE:

This study was led by Judith Prochaska, PhD, Stanford University School of Medicine in Stanford, California. It was published online on September 17, 2025, in Thorax.

LIMITATIONS:

COPD diagnosis was based on participant self-report and was not confirmed via spirometry. Additionally, data on COPD severity were not collected in the parent trials, limiting the ability to assess potential interactions between disease severity and treatment outcomes.

DISCLOSURES:

This study was funded by Achieve Life Sciences. Three authors were employees of the funding company. One author provided consultation to Achieve Life Sciences and other pharmaceutical companies, and another author provided biostatistics consultation.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.