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Achieve Life Sciences Reports Statistically Significant Smoking Cessation Benefit for Cytisinicline in Second, Confirmatory Phase 3 Clinical Trial
ORCA-3 demonstrated statistically significant topline results in primary and secondary smoking cessation endpoints for both 6- and 12-week cytisinicline
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"ORCA-3 demonstrated statistically significant topline results in primary and secondary smoking cessation endpoints for both 6- and 12-week cytisinicline treatment durations compared to placebo Cytisinicline demonstrated 6x increase in odds of continuous smoking abstinence at 6 months Cytisinicline treatment well tolerated with low rates of adverse events reported Management to host conference call today, May 23 at 8:30AM EDT SEATTLE and VANCOUVER, British Columbia, May 23, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today 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. The primary endpoint for ORCA-3 was biochemically verified smoking cessation measured during the last 4 weeks of treatment. Subjects were monitored for smoking cessation for 24 weeks post randomization. Both the 6- and 12-week cytisinicline treatment durations demonstrated statistically significant smoking cessation on both the primary and secondary efficacy analyses compared to placebo. 12-Week Cytisinicline Efficacy Results Primary Endpoint: Subjects who received 12 weeks of cytisinicline treatment had 4.4 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p","length":2621,"tagName":"div"}]