Researchers have found that cytisinicline effectively and safely assisted people with smoking cessation when used at a higher concentration than typically used in Europe.

Participants in the ORCA-2 trial received cytisinicline as a 3-mg tablet taken orally three times per day for 6 weeks. According to findings published in JAMA, this was associated with higher continuous abstinence rates for smoking during Weeks 3 to 6 and Weeks 3 to 24 compared to the use of a placebo.

Among patients taking cytisinicline for 12 weeks, they demonstrated continuous abstinence rates of 32.6% versus 7.0% in the placebo group for Weeks 9 to 24. All three sections of the ORCA-2 trial reported high percentages of behavioral support compliance, with 92.8% of sessions completed in the 12-week group, 89.5% in the 6-week group, and 86.8% in the placebo cohort.

Adverse effects such as insomnia, nausea, and strange dreams occurred in <10% of each group, but caused 2.9% of cytisinicline recipients and 1.5% of patients in the placebo group to withdraw from the trial. Serious adverse events were seen in 3.3% and 1.1%, respectively, but were deemed to be unrelated to the treatment.

“Cytisinicline reduced nicotine craving and was well tolerated by participants who adhered to the treatment schedule at a high rate, even though the trial was conducted during the early phases of the U.S. COVID-19 pandemic,” wrote study authors.

Results are expected to help support a request for FDA approval for cytisinicline, which is available as an OTC smoking cessation product in Eastern and Central Europe.