Achieve Life Sciences Inc. (NASDAQ: ACHV) presented long-term safety data from its ORCA-OL study showing cytisinicline maintained a favorable safety profile over 52 weeks of continuous treatment for nicotine dependence.

The open-label study enrolled 475 adults who smoke cigarettes, use e-cigarettes, or both. Participants received cytisinicline 3 mg three times daily for up to 52 weeks, with a median duration of 361 days. The study population included smokers (84.6%), e-cigarette users (12.8%), and dual users (2.5%).

Among participants, 66.3% experienced treatment-emergent adverse events, with 94.8% classified as mild or moderate in severity. Serious adverse events occurred in 6.5% of participants. The most common adverse events were abnormal dreams (8.4%), insomnia (8.4%), and upper respiratory tract infection (6.7%). Nausea was reported in 2.5% of participants, and 5.7% discontinued treatment due to treatment-related adverse events.

The independent Data Safety Monitoring Committee identified no new safety signals during the 52-week exposure period. The findings complete the clinical evidence package supporting the company's New Drug Application (NDA) for cytisinicline as a smoking cessation treatment.

The FDA accepted Achieve's NDA for review in September 2025, assigning a Prescription Drug User Fee Act date of June 20, 2026. The application is based on two Phase 3 studies and the open-label safety study.

"The ORCA-OL dataset provides important long-term safety and tolerability information across a broad population of adults with nicotine dependence," said Mark Rubinstein, the company's chief medical officer.

Cytisinicline is a plant-based alkaloid designed to aid smoking and e-cigarette cessation by interacting with nicotine receptors in the brain. The FDA has granted the drug Breakthrough Therapy designation for e-cigarette cessation.