Nicotine is an addictive substance present in both combustible and electronic cigarettes (e-cigarettes). Nicotine dependence is a major public health concern. Achieve Life Sciences Inc (Achieve) is dedicated to developing new therapies for treating nicotine dependence.

Smoking cessation, or quitting smoking, has a positive impact on individual patient health and on patient families. Achieve is currently focused on getting cytisinicline approved with the Food and Drug Administration (FDA) as a new drug therapy for treating nicotine dependence to help people quit smoking (i.e., smoking cessation). The last FDA approval for a drug therapy for smoking cessation was in 2006. Achieve has successfully completed two required Phase 3 clinical studies demonstrating cytisinicline’ s benefit in helping people, who smoke, quit combustible cigarettes. Achieve has recently received “Breakthrough Therapy Designation” for cytisinicline as a new treatment for adults who are dependent on nicotine vaping and want to quit e-cigarettes/vaping. There are currently no FDA approved drug treatments to help people quit e-cigarettes or nicotine vaping.

Consistent with Achieve’s mission to bring innovative medicines to people with nicotine dependence, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make cytisinicline broadly available as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop this new and effective cytisinicline therapy. At this time, Achieve is committed to delivering our investigational therapy to patients through clinical trials and does not have an expanded access program that would allow patients to have access to our investigation drug candidate outside of enrollment in our clinical trials. Information about Achieve-sponsored clinical trials can be found on our website and at https://clinicaltrials.gov/ under trials listed for Achieve Life Sciences Inc.