Achieve Life Sciences Announces Last Subject Last Visit Completed in Phase 3 ORCA-3 Trial of Cytisinicline for Smoking Cessation

About this update from Achieve Life Sciences, Inc.

[{"type":"text","content":"Topline Data Expected in 2Q 2023\nSEATTLE, Wash. and VANCOUVER, British Columbia, March 29, 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 that the last study follow-up visit for the last subject enrolled in the Phase 3 ORCA-3 trial has occurred.“We are pleased to have reached this final milestone in the Phase 3 ORCA-3 trial and continue to expect topline data results from this trial, as well as results from the ORCA-V1 trial of cytisinicline as a treatment for e-cigarette cessation, to be reported in the second quarter of this year,” commented John Bencich, Chief Executive Officer of Achieve.The ORCA-3 trial randomized 792 subjects across 20 clinical locations in the United States. Similar to the Phase 3 ORCA-2 trial, participants received 3mg cytisinicline dosed 3 times daily for either 6 or 12 weeks and were monitored through 24 weeks post randomization. The trial is blinded, placebo-controlled, and all subjects received behavioral support for the duration of the trial. Biochemically verified continuous abstinence during the last four weeks of treatment is the trial’s primary endpoint. The trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit when compared independently to the placebo arm.ORCA-3 is designed to enable U.S. Food and Drug Administration, or FDA, registration of cytisinicline for the treatment of smoking cessation. If approved, it would be the first, non-nicotine smoking cessation prescription treatment made available to smokers in the U.S. in nearly two decades.For more information on cytisinicline or the ORCA-3 trial, please visit www.achievelifesciences.com.About Achieve and Cytisinicline Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart diseas...

More updates from Achieve Life Sciences, Inc.