ACHV - Achieve Life Sciences launches late-stage study of cytisinicline for smoking cessation

Achieve Life Sciences (ACHV) has initiated Phase 3 ORCA-2 clinical trial, evaluating the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the U.S.The participants will be randomized to one of three study arms of cytisinicline administered for either 6 or 12 weeks, compared to placebo. The primary outcome measure of success is the continuous abstinence during the last four weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm, and trial success will be determined if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo.Secondary outcome measures will be conducted to assess continued abstinence rates through 6 months from the start of study treatment.

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Achieve Life Sciences launches late-stage study of cytisinicline for smoking cessation