Achieve Life Sciences announced that its New Drug Application (NDA) for the smoking cessation drug Cytisinicline has been accepted by the U.S. Food and Drug Administration (FDA), with the review process set to commence. The Prescription Drug User Fee Act (PDUFA) target date is June 20, 2026. The drug’s development is based on a decade of research and clinical trial data from over 2,000 participants.
Key Highlights:
- Achieve Life Sciences announced that its New Drug Application (NDA) for the smoking cessation drug Cytisinicline has been accepted by the U.S. Food and Drug Administration (FDA).
- The Prescription Drug User Fee Act (PDUFA) target date is set for June 20, 2026.
- The drug’s development is based on a decade of research and clinical trial data from over 2,000 participants.
The U.S. FDA has accepted the application for the smoking cessation drug Cytisinicline.
September 4, 2025 – Achieve Life Sciences (Nasdaq: ACHV), a company focused on developing and commercializing the nicotine dependence treatment Cytisinicline, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Cytisinicline. This acceptance marks the commencement of the FDA’s review process. The Prescription Drug User Fee Act (PDUFA) target action date is June 20, 2026.
The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from pharmaceutical companies to expedite the review and approval process for new drugs, establishing a PDUFA date—the deadline by which the FDA must make a decision (approval, disapproval, or request for additional information) on the new drug application.
Review expected to be completed by June 2026
Dr. Cindy Jacobs, President and Chief Medical Officer of Achieve Life Sciences, stated: “The FDA’s acceptance of our NDA validates the full scope of our product development program. Our submission is supported by a decade of rigorous research and comprehensive data from thousands of participants. Upon approval, Cytisinicline has the potential to address an unmet medical need.”
The drug’s development is based on a decade of research
The company’s NDA details a comprehensive clinical development program, including evidence from over 2,000 participants in clinical trials. Phase 3 trials ORCA-2 and ORCA-3 demonstrated that patients receiving 6 to 12 weeks of Cytisinicline treatment combined with standard behavioral support achieved significantly higher smoking cessation rates compared to placebo. Sustained efficacy was maintained through 24 weeks. Additionally, safety data from over 400 participants receiving at least 6 months of Cytisinicline treatment and more than 200 participants treated for over a year revealed no new safety concerns reported by the Data Safety Monitoring Board.
Rick Stewart, CEO of Achieve Life Sciences, stated: “Smoking causes nearly 500,000 deaths annually in the United States and results in over $600 billion in economic losses. The FDA’s acceptance of our application reflects the urgency of nicotine dependence as a significant public health need. We are prepared for market launch in the second half of 2026. Approximately 15 million Americans attempt to quit smoking each year. We are committed to providing tools for those ready to quit, helping them overcome nicotine dependence.”
