Cytisinicline Treatment Results in Significant Smoking Cessation in Adults


New data from phase 3 of the ORCA-2 trial found that adults treated 3 times daily with cytisinicline were more inclined to quit smoking cigarettes.

Cytisinicline Treatment Results in Smoking Cessation in Adults

Nancy Rigotti, MD

Today, Achieve Life Sciences announced positive topline data on cytisinicline from phase 3 of the ORCA-2 trial, which indicated that participants who received 12 weeks of cytisinicline treatment were 6.3 times more likely to quit smoking during the last 4 weeks of treatment compared to those who received placebo.

Meanwhile, subjects who received 6 weeks of cytisinicline treatment had 8 times higher odds of quitting smoking during the last 4 weeks of treatment compared to subjects who received placebo.

The ORCA-2 trial evaluated the efficacy and safety of 3 mg cytisinicline in 3 daily doses for a period of 6-weeks or 12-weeks compared to placebo in 810 adult smokers. Most participants were an average of 54 years old and smoked roughly 20 cigarettes per day at baseline with a median smoking history of 38 years and 4 prior attempts at quitting.

The trial also measured continuous abstinence following treatment out to 24 weeks, and found that the abstinence rate during weeks 9-12 was 32.6% for the 12-week cytisinicline treatment group and 25.3% for the 6-week cytisinicline treatment group.

“Cytisinicline demonstrated impressive efficacy for smoking cessation compared to placebo in this trial, the first large randomized clinical trial conducted in a U.S. population,” said Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School, and Principal Investigator of ORCA-2. “The trial is also notable as the first one to test the long-term efficacy of a new cytisinicline dosing schedule that has not previously been tested in a large population.”

Though cytisinicline was well tolerated with no treatment-related serious adverse events being reported, common (>5%) adverse events included insomnia, abnormal dreams, headaches, and nausea.

In a press release issued by Achieve Life Sciences, CEO of the pharmaceutical company John Bencich found the results of the ORCA-2 trial to be “extremely encouraging”, adding that the trial confirms that “cytisinicline, if approved by the FDA, has the potential to become the first new agent approved in nearly 2 decades and an important treatment option for smoking cessation, which is much needed given the limitations, particularly the significant side effects associated with existing agents.”

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