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Achieve Life Sciences announces last subject dosed in Phase 3 ORCA-3 trial
The Fly

Achieve Life Sciences announces last subject dosed in Phase 3 ORCA-3 trial

Achieve Life Sciences announced that the final subject of the Company’s Phase 3 ORCA-3 trial has completed treatment in the study. Similar to the previously reported ORCA-2 trial, ORCA-3 is evaluating the smoking cessation efficacy, safety, and tolerability of 3 mg cytisinicline dosed three times daily for either 6 or 12 weeks compared with placebo. "With the milestone achieved of last ORCA-3 subject completing study treatment, we are pleased to remain on schedule for announcing data results as expected in the second quarter," stated John Bencich, Chief Executive Officer of Achieve. "It will be a busy and exciting year ahead with the completion of both ORCA-3 and ORCA-V1, evaluating cytisinicline for e-cigarette cessation, and the preparation for FDA filing in the U.S., which is already underway." The ORCA-3 trial randomized 792 subjects in total across 20 clinical trial locations in the United States. Participants are being monitored through 24 weeks post randomization and will receive standard behavioral support for the duration of the trial. The ORCA-3 primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment.

Published first on TheFly

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