Achieve Life Sciences Announces Initiation of Phase 2 ORCA-V1 Clinical Trial Evaluating Cytisinicline for Nicotine e-cigarette Cessation
During the first phase, Achieves Investigational New Drug application for nicotine e-cigarette cessation was reviewed and accepted by the U.S. Food and Drug Administration (FDA) late last year.
- During the first phase, Achieves Investigational New Drug application for nicotine e-cigarette cessation was reviewed and accepted by the U.S. Food and Drug Administration (FDA) late last year.
- In addition to the initiated ORCA-V1 trial, Achieve is evaluating smoking cessation of combustible cigarettes in its Phase 3 clinical development program.
- The ORCA-2 clinical trial, which was comprised of 810 adult smokers, announced positive topline results in April.
- The ORCA-3 trial, the intended confirmatory Phase 3 trial required for regulatory submission of cytisinicline, is currently enrolling smokers at 15 clinical trial locations in the United States.