Clinical TrialMay 19, 2026, 02:16 PM
Achieve Life Sciences Completes Cytisinicline NDA Clinical Evidence
AI Summary
Achieve Life Sciences announced the presentation of comprehensive long-term safety data from its ORCA-OL study for cytisinicline at the American Thoracic Society 2026 Annual Meeting. The study demonstrated a favorable safety profile over 52 weeks of continuous exposure in a diverse population, with no new safety signals identified by the independent Data Safety Monitoring Committee and a low incidence of nausea (2.5%). This final clinical dataset completes the comprehensive evidence package supporting the company's New Drug Application (NDA) for cytisinicline as a treatment for nicotine dependence, moving it closer to potential approval.
Key Highlights
- ORCA-OL study enrolled 475 adults who smoke or use e-cigarettes.
- Participants received cytisinicline for up to 52 weeks of continuous exposure.
- Median cumulative exposure duration was 361 days.
- Nausea was reported in only 2.5% of participants over 52 weeks.
- 94.8% of adverse events were mild or moderate in severity.
- Serious adverse events were reported in 6.5% of participants.
- Only 5.7% of participants discontinued due to treatment-related adverse events.
- NDA accepted in September 2025 with PDUFA date of June 20, 2026.
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