Achieve Life Sciences (ACHV) announced the outcome of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration. This meeting represents a key milestone in advancing cytisinicline’s development as a potential first-in-class treatment for nicotine e-cigarette or vaping cessation. Achieve obtained FDA agreement on the proposed single Phase 3 study design for cytisinicline treatment in vaping cessation and on the additional requirements for submitting a supplemental new drug application to expand cytisinicline for the treatment for vaping cessation. The End-of-Phase 2 meeting resulted in alignment with the FDA on the proposed Phase 3 study design, including the inclusion/exclusion criteria, primary and secondary efficacy objectives, definition of vaping abstinence with biochemical verification, and other overall study assessments. The FDA agreed that one well-controlled Phase 3 trial in addition to Achieve’s completed Phase 2 ORCA-V1 trial, would be acceptable for a vaping cessation indication as an sNDA. Additionally, the FDA agreed that the company’s safety exposure data from the ongoing ORCA-OL study would be adequate for the vaping cessation label expansion. The Phase 3 ORCA-V2 trial will assess the efficacy and safety of cytisinicline for nicotine e-cigarette cessation, building on the previous Phase 2 vaping cessation trial as well as the Phase 3 smoking cessation clinical trials with cytisinicline. The trial population and design are similarly aligned with Achieve’s successful Phase 2 ORCA-V1 trial. Achieve is currently targeting ORCA-V2 to initiate in the third quarter of 2025. Key study design highlights include: Study Population: Adults 18 years of age or older who are dependent on nicotine e-cigarettes and who have failed at least one previous attempt to stop vaping nicotine. Study Design: ORCA-V2 will evaluate the efficacy and safety of 3 mg cytisinicline dosed three times daily for 12 weeks compared to placebo in approximately 800 adults who use e-cigarettes or nicotine vapes and do not currently smoke cigarettes. All participants will receive behavioral support for nicotine cessation and will be assessed throughout the 24-week trial duration. Study Objectives: The primary objective for ORCA-V2 mirrors the Phase 2 ORCA-V1 trial objective and will be weekly vaping abstinence with biochemical confirmation, measured during the last four weeks of treatment, weeks 9 to 12. The secondary objective will evaluate continuous vaping cessation from weeks 9 to 24. Safety, adherence to study treatment, and other patient-reported outcomes on vaping urges and craving symptoms will also be collected.
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