Cytisinicline at least as effective as varenicline for smoking cessation

Achieve Life Sciences announced positive top-line results of the RAUORA trial demonstrating that cytisinicline was noninferior to varenicline for smoking cessation.

“We found that cytisinicline was just as good as Chantix in helping people to quit smoking

and stay quit. In addition, we found that fewer people in the cytisinicline group reported any side effects from the medicine compared to those in the Chantix group,” Natalie Walker, PhD, DPH, MSc, BSc, associate professor at the University of Auckland in New Zealand and principal investigator for the RAUORA trial, said in a press release issued by Achieve Life Sciences.

RAUORA is a phase 3, head-to-head, noninferiority clinical trial designed to compare the effectiveness, safety and cost-effectiveness of cytisinicline as a smoking-cessation aid compared with varenicline (Chantix, Pfizer).

Cytisinicline is a plant-based alkaloid with high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain and reducing the severity of nicotine withdrawal symptoms and also by reducing the reward and satisfaction associated with smoking, according to the release.

The trial was conducted in Maori Indigenous New Zealanders and whanau extended family members of the Maori. Currently, 3 in 10 Maori smoke, according to the release. This population has the highest prevalence of smoking in New Zealand and the slowest decline in prevalence during the past 2 decades, according to Walker.

A total of 679 patients (average age, 43 years; 70% women) were randomly assigned to 12 weeks of treatment with cytisinicline or varenicline. Treatment was administered on a schedule of 25 days of downward dosing titration followed by twice-daily dosing for 12 weeks; varenicline was administered on a schedule of 7 days of upward titration followed by twice-daily dosing for 12 weeks. Primary endpoint was biochemically confirmed continuous smoking abstinence rates at 6 months, according to the release.

According to the top-line results announced via press release, cytisinicline plus behavioral support was at least as effective as varenicline plus behavioral support at 6 months. Additionally, cytisinicline resulted in significantly fewer adverse events compared with varenicline.

Full results from the RAUORA trial will be presented at the Society for Research on Nicotine and Tobacco Europe Annual Meeting in September. Healio will report the full data when made available.