News
Tag: Clinical News
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Achieve Life Sciences Announces Publication of Cytisinicline Vaping Cessation Trial Results in JAMA Internal Medicine
Phase 2 ORCA-V1 trial showed treatment with cytisinicline more than doubled odds of quitting e-cigarettes compared with placebo. Cytisinicline treatment well tolerated with no serious adverse events reported and excellent compliance to study treatment. Achieve expects to conduct an End-of-Phase 2 Meeting with the FDA later this year to discuss Phase 3 trial plans. SEATTLE…
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Achieve Life Sciences Announces Data from Cytisinicline ORCA Program to be Presented at the 2024 Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting
SEATTLE and VANCOUVER, British Columbia, March 20, 2024 (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 three oral presentations featuring data from both of the Phase 3 ORCA-2 and ORCA-3 clinical trials…
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Achieve Life Sciences Reaches Agreement with the FDA on Long-Term Cytisinicline Exposure Data Requirements for NDA Submission
Open-label exposure trial expected to initiate in Q2’24 with NDA filing anticipated in 1H 2025. SEATTLE, Wash. and VANCOUVER, British Columbia, February 29, 2024 (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…
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Achieve Life Sciences Announces Presentation of Cytisinicline E-Cigarette Cessation (ORCA-V1) Results at Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting
SEATTLE and VANCOUVER, British Columbia, Sept. 11, 2023 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Phase 2 ORCA-V1 trial results will be presented at the Society for Research on Nicotine…
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Achieve Life Sciences Announces Publication of Cytisinicline Phase 3 ORCA-2 Smoking Cessation Trial in Journal of the American Medical Association (JAMA)
Cytisinicline 6- and 12-week dosing schedules, with behavioral support, demonstrated “smoking cessation efficacy and excellent tolerability” Supports potential for cytisinicline to be the first pharmacotherapy approved for smoking cessation in nearly two decades. SEATTLE, Wash and VANCOUVER, British Columbia, July 11, 2023 — Achieve Life Sciences, Inc. (NASDAQ: ACHV), today announced the publication in JAMA…