Achieve Life Sciences Confirms Promotion of Dr. Mark Rubinstein to Chief Medical Officer

Core Viewpoint - Achieve Life Sciences has promoted Dr. Mark Rubinstein to Chief Medical Officer following his successful tenure as Interim CMO, during which the company achieved significant clinical and regulatory milestones in the development of cytisinicline for smoking cessation [1][2][3]. Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence [5]. - The company submitted a New Drug Application (NDA) to the FDA in June 2025, which has been accepted for review, with a Prescription Drug User Fee Act (PDUFA) date set for June 20, 2026 [5]. Clinical Development - Under Dr. Rubinstein's leadership, Achieve Life Sciences has co-authored a paper demonstrating the efficacy and tolerability of cytisinicline for smoking cessation in individuals with Chronic Obstructive Pulmonary Disease (COPD) [2]. - Cytisinicline has shown a robust safety profile in long-term trials, indicating its potential to address unmet medical needs related to nicotine dependence [4]. Market Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death, responsible for over 8 million deaths globally and nearly half a million in the U.S. annually [6]. - There are around 17 million adults in the U.S. who use e-cigarettes, with no FDA-approved treatments specifically for nicotine e-cigarette cessation [7]. Product Mechanism - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, helping to reduce nicotine cravings and the satisfaction associated with nicotine products [8].