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Achieve Life Sciences Announces Successful, Statistically Significant Smoking Cessation Results in Phase 3 ORCA-2 Clinical Trial of Cytisinicline in Adult Smokers
Clinically robust and statistically significant results in primary and secondary endpoints for both 6- and 12-week cytisinicline treatment compared to placebo
About this update from Achieve Life Sciences, Inc.
[{"type":"text","content":"Clinically robust and statistically significant results in primary and secondary endpoints for both 6- and 12-week cytisinicline treatment compared to placebo Primary endpoints demonstrated 6-8x increased odds of smoking abstinence with cytisinicline compared to placebo Cytisinicline was well tolerated with single-digit rates of adverse events observed Management to host conference call today, April 27th at 8:30AM EST SEATTLE and VANCOUVER, British Columbia, April 27, 2022 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), today announced positive topline results from the Phase 3 ORCA-2 trial of cytisinicline. ORCA-2 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 in 810 adult smokers (randomized 1:1:1). Subjects were monitored for smoking abstinence for 24 weeks post randomization and received standard behavioral support for the duration of the trial. The primary endpoints for ORCA-2 were biochemically verified continuous abstinence measured during the last 4 weeks of treatment. Both the 6- and 12-week cytisinicline treatments demonstrated significantly better quit rates than placebo with odds ratios of 8.0 and 6.3, respectively. Subjects who received 12 weeks of cytisinicline treatment had 6.3 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p","length":2038,"tagName":"div"}]