Achieve Life Sciences Shows 2.5% Nausea Rate in 52-Week Cytisinicline Safety Trial
Achieve Life Sciences’ ORCA-OL trial of 475 adults found no new safety signals over 52 weeks of cytisinicline exposure, with 2.5% reporting nausea and a 5.7% discontinuation rate. This dataset completes the New Drug Application safety package and bolsters cytisinicline’s tolerability profile ahead of its June 20, 2026 PDUFA decision.
1. ORCA-OL Trial Design and Results
The open-label ORCA-OL trial enrolled 475 adults who smoke combustible cigarettes, use e-cigarettes or both, administering 3 mg cytisinicline thrice daily for up to 52 weeks with a median exposure of 361 days. No new safety signals emerged during the extended exposure period.
2. Safety and Tolerability Findings
Treatment-emergent adverse events occurred in 66.3% of participants, of which 94.8% were mild or moderate. The most common events were abnormal dreams (8.4%), insomnia (8.4%) and upper respiratory infections (6.7%), with nausea at just 2.5% and a 5.7% discontinuation rate for treatment-related events.
3. Regulatory Implications
This final long-term safety dataset completes the clinical evidence package for the cytisinicline New Drug Application, positioning the therapy for potential approval. A Prescription Drug User Fee Act review is underway with a PDUFA decision expected on June 20, 2026.