Expanded Access Policy

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

AchieveRx has completed three Phase 3 trials evaluating the safety and efficacy of cytisinicline, an investigational medicine. Achieve is currently seeking FDA approval of cytisinicline as an aid to smoking cessation treatment in adults.

The FDA has also granted cytisinicline Breakthrough Therapy Designation for cytisinicline as a new treatment for adults who are dependent on nicotine vaping and want to quit e-cigarettes/vaping.

Our Policy. At this time, AchieveRx provides cytisinicline only through its clinical trials and does not offer expanded access outside them. Information about AchieveRx-sponsored clinical trials is available at ClinicalTrials.gov. AchieveRx is committed to re-evaluation of this policy as development progresses.