A Achieve Life Sciences, Inc. announced positive topline results from the Phase 3 ORCA-3 trial of cytisinicline. Consistent with the previously reported Phase 3 ORCA-2 study, ORCA-3 showed a statistically significant benefit in helping people to quit smoking compared to placebo, with low rates of adverse events. ORCA-3 was designed to evaluate the efficacy and safety of 3mg cytisinicline dosed 3 times daily for a period of 6 weeks or 12 weeks compared to placebo.

ORCA-3 randomized 792 adult smokers at 20 clinical trial sites in the United States. All participants received standard behavioral support for the duration of the trial. If approved, cytisinicline could be the first new prescription treatment in nearly 20 years to help the millions of people who smoke to overcome nicotine dependence.

The Phase 3 ORCA-3 study evaluated 792 adults who smoked cigarettes on a daily basis at 20 clinical trial locations in the United States. The trial was initiated in January 2022 and completed enrollment in September 2022, with topline results reported in May 2023.