Achieve Life Sciences Gains FDA Acceptance Of New Drug Application For Cytisinicline To Aid Adults Battling Nicotine Dependence

Achieve Life Sciences, Inc., a late-stage specialty pharmaceutical company dedicated to the global development and commercialization of cytisinicline for the treatment of nicotine dependence, has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for cytisinicline as a new treatment for smoking cessation in adults. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 20, 2026.

The NDA submission is supported by a robust clinical development program involving more than 2,000 participants across multiple trials. Key evidence comes from the ORCA-2 and ORCA-3 Phase 3 studies, which demonstrated that cytisinicline, administered for either 6 or 12 weeks alongside standard behavioral support, resulted in significantly higher rates of smoking abstinence compared to placebo. Importantly, the trials confirmed benefits not only at the end of treatment but also in maintaining long-term abstinence through week 24.

Dr. Cindy Jacobs, President and Chief Medical Officer of Achieve Life Sciences, stated, “The FDA’s acceptance of our NDA validates the totality of our product development program. Our application is supported by a decade of rigorous research and comprehensive data from thousands of participants. We’ve built compelling scientific and clinical results as a foundation that, if approved, positions cytisinicline to potentially address a significant medical need. We’re eager to engage constructively with the FDA as we progress through the NDA review process.”

Rick Stewart, Chief Executive Officer of Achieve Life Sciences, said in a statement, “Smoking is the leading cause of preventable death and disease, claiming the lives of nearly half a million Americans each year, and costing the American economy more than an estimated $600 billion a year. The FDA’s acceptance of our NDA filing underscores nicotine dependence as an important public health need that demands action. We’re energized by this milestone and remain laser-focused on our mission, working toward commercial readiness for the second half of 2026, pending FDA approval. Each year, an estimated 15 million Americans attempt to quit smoking, and we’re committed to providing those who are ready to quit a new tool so they can break free from nicotine dependence.”

The safety profile of cytisinicline is also well established, with data including over 400 participants who received at least six months of cumulative treatment exposure and more than 200 participants who received at least one year of cumulative exposure. Across this extensive safety database, no new safety concerns have been identified, as confirmed by the independent Data Safety Monitoring Committee. This milestone brings Achieve Life Sciences closer to potentially delivering a new therapeutic option for adults seeking to quit smoking, addressing a significant public health need.