Achieve Life Sciences Reports New Data Supporting Cytisinicline For Smoking Cessation Across Diverse Patient Histories

Achieve Life Sciences, Inc. announced new clinical findings indicating that its investigational treatment cytisinicline, can help individuals successfully quit smoking after both six and twelve weeks of therapy, regardless of their previous experience with smoking cessation medications or the number of prior quit attempts. The company is currently advancing cytisinicline as a potential treatment for nicotine dependence.

The analysis combines results from the Phase 3 ORCA-2 and ORCA-3 trials, which together included 1,602 participants attempting to quit smoking. Researchers evaluated outcomes based on participants’ past use of cessation therapies, including varenicline, bupropion, and nicotine replacement therapy (NRT). The results showed that cytisinicline maintained consistent effectiveness across these groups, suggesting the therapy may benefit a wide range of individuals seeking to overcome nicotine addiction.

“In this analysis, cytisinicline helped people to quit smoking, even those individuals who had failed previous quit attempts or had used FDA-approved smoking cessation medications without success,” said Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School, Director of Tobacco Research and Treatment Center, Massachusetts General Hospital, and ORCA Program Investigator. “Many people have to try to quit several times before they become smoke-free. This finding should offer hope to patients whose prior setbacks might have discouraged them from trying to quit smoking again.”

The study also assessed outcomes by the number of prior quit attempts. Participants who had made four or fewer attempts to quit and those with more than four attempts both experienced meaningful quitting success with cytisinicline treatment. These findings highlight the therapy’s potential effectiveness even among individuals with long histories of unsuccessful cessation efforts.

In addition to the pooled trial analysis, Achieve will present late-breaking survey findings from the ORCA-OL study, a long-term, open-label safety trial evaluating extended use of cytisinicline. The study followed participants for up to one year to assess the safety profile and patient experiences associated with prolonged treatment.

“Patient experience is hugely important for those trying to quit smoking,” said Dr. Mark Rubinstein, Chief Medical Officer of Achieve Life Sciences. “It is encouraging to see trial participants describing meaningful benefits, including successful quitting and improvements in physical health. We're committed to supporting people who want to quit smoking at every stage, whether they're trying to quit for the first time or making another attempt.”

The voluntary post-trial survey collected patient-reported feedback on the extended use of cytisinicline beyond the previously studied six- and twelve-week treatment durations. These insights are expected to provide a deeper understanding of how the therapy affects individuals attempting to quit nicotine and how it may support long-term smoking cessation.