Achieve Life Sciences Begins ORCA-OL Trial on Long-Term Cytisinicline Exposure in Smokers and E-Cigarette Users

Achieve Life Sciences, Inc., a late-stage pharmaceutical company, has begun screening participants for its open-label ORCA-OL clinical trial. This trial, taking place at 29 locations across the United States, aims to gather long-term safety data on cytisinicline, a drug designed to aid smoking and nicotine e-cigarette cessation. The data collected will support a New Drug Application (NDA) submission, anticipated in the first half of 2025. 

Cytisinicline is a plant-derived alkaloid known for its high binding affinity to nicotinic acetylcholine receptors. It is believed to help reduce nicotine addiction by mitigating withdrawal symptoms and decreasing the satisfaction derived from nicotine products. This makes it a promising candidate for those looking to quit both smoking and vaping, a unique feature as no current FDA-approved treatments specifically target e-cigarette cessation.

The ORCA-OL study focuses on U.S. adults who wish to quit smoking or vaping, particularly those who participated in previous ORCA Phase 2 or Phase 3 trials but have relapsed. Participants will receive a 3 mg dose of cytisinicline three times daily. This study is crucial for meeting the FDA's requirements, which include providing safety data on at least 300 subjects treated for six months and 100 subjects treated for a year. These data points are essential for the potential approval and marketing of cytisinicline in the United States.

Cindy Jacobs, PhD, MD, President and Chief Medical Officer of Achieve, expressed optimism about the trial's enrollment process. The company received enthusiastic responses from former study participants, with about two-thirds showing interest in rejoining, although around a quarter are ineligible due to sustained abstinence from smoking or vaping since their last trial participation.

Achieve has already conducted successful randomized Phase 3 clinical trials for smoking cessation and a placebo-controlled Phase 2 trial for those wishing to quit nicotine e-cigarettes. These trials have demonstrated cytisinicline's excellent safety profile and significantly increased the likelihood of quitting nicotine compared to placebo treatments with behavioral support.

Tobacco use remains the leading cause of preventable death, responsible for over eight million deaths worldwide and nearly half a million annually in the U.S. alone. Smoking is linked to the majority of lung cancer deaths, a significant percentage of pulmonary disease deaths, and many coronary heart disease fatalities. In addition, over 11 million U.S. adults use e-cigarettes, with millions of middle and high school students also reporting usage. Despite these alarming numbers, there have been no new FDA-approved treatments for smoking cessation in nearly two decades, nor any specifically for e-cigarette cessation.

Achieve targets its NDA submission for the first half of 2025. If approved, cytisinicline could become a vital tool for millions struggling with nicotine dependence. The company remains committed to addressing the global smoking and nicotine addiction epidemic through the development and potential commercialization of this promising treatment.

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