Achieve Life Sciences announced the appointment of Dr. Mark Rubinstein as Interim Chief Medical Officer, marking a key leadership transition as the late-stage pharmaceutical company advances its smoking cessation drug cytisinicline through FDA review. The appointment comes as the company maintains momentum following recent FDA acceptance of its New Drug Application.
Dr. Rubinstein brings extensive experience in nicotine dependence treatment to his new role. Prior to joining Achieve Life Sciences as Head of Medical Affairs in October 2024, he served as Head of Medical Affairs at Blip, where he led strategies to help smokers and vapers quit through FDA-approved medications and digital support tools. His background also includes serving as Vice President of Global Scientific Affairs at Juul Labs, focusing on preventing youth nicotine product usage.
"We are pleased to appoint Mark to this critical role and know that his leadership will ensure long-term success as we work to solve the public health crisis of nicotine dependence," said Rick Stewart, CEO of Achieve Life Sciences. The company recently received FDA acceptance of its cytisinicline New Drug Application with a PDUFA completion date of June 20, 2026.
Regulatory Progress and Market Opportunity
The FDA's acceptance of the cytisinicline NDA represents a significant milestone for addressing nicotine dependence. The company targets the estimated 15 million American adults who attempt to quit smoking each year, representing a substantial market opportunity in smoking cessation therapeutics.
Cytisinicline has received FDA Breakthrough Therapy designation specifically for e-cigarette cessation, addressing a critical unmet medical need. Currently, no FDA-approved treatments are indicated specifically as an aid to nicotine e-cigarette cessation, despite approximately 17 million adults in the United States using e-cigarettes.
Mechanism and Clinical Development
Cytisinicline is a plant-derived alkaloid with high binding affinity to the nicotinic acetylcholine receptor. The drug is believed to aid in treating nicotine dependence by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products.
The company has completed a Phase 2 study with cytisinicline in vaping cessation and conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication. This dual approach addresses both traditional smoking cessation and the growing challenge of e-cigarette dependence.
Public Health Impact
The therapeutic need for effective smoking cessation treatments remains substantial. Tobacco use is currently the leading cause of preventable death, responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually. More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.
The e-cigarette epidemic among youth adds urgency to developing effective cessation treatments. In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes, highlighting the need for evidence-based interventions.
Dr. Rubinstein's academic credentials include serving as Professor Emeritus of Pediatrics at the University of California, San Francisco, where he was on faculty for nearly 20 years. He earned his M.D. from Yale University and completed his residency in Internal Medicine at Yale-New Haven Hospital.
The leadership transition positions Achieve Life Sciences to advance cytisinicline through the regulatory review process while preparing for potential commercialization. With approximately 29 million adults in the United States smoking combustible cigarettes, the company aims to provide a new therapeutic option for nicotine dependence treatment.
