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Achieve Life Sciences submits 120-day safety update to FDA for cytisinicline.
ByAinvest
Monday, Nov 3, 2025 8:44 am ET1min read
Achieve Life Sciences has submitted a 120-day safety update to the FDA as part of the NDA review for cytisinicline, a treatment for nicotine dependence. The ORCA-OL long-term safety trial has concluded successfully, with no drug safety concerns found by the Data and Safety Monitoring Committee. The trial includes data on 411 participants with at least six months of cumulative exposure to cytisinicline.
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