Achieve Life Sciences Announces Publication of Cytisinicline Phase 3 ORCA-2 Smoking Cessation Trial in Journal of the American Medical Association (JAMA) - Seite 3

“We believe the body of evidence to date shows that cytisinicline effectively increases cessation rates without causing troublesome side effects, which often, are a key reason patients refuse to take or continue prescription cessation medications,” said Cindy Jacobs, MD, PhD, Achieve Life Sciences President and Chief Medical Officer. “If approved by regulators, cytisinicline has the potential to become the new standard of care for the millions of people who want to quit smoking.”

About ORCA-2 
The Phase 3 ORCA-2 trial evaluated 810 adults who smoked cigarettes on a daily basis at 17 clinical trial locations in the United States. The trial was initiated in October 2020 and completed enrollment in June 2021, with topline results reported in April 2022. ORCA-2 participants received 3mg cytisinicline dosed 3 times daily for either 6 or 12 weeks and were monitored through 24 weeks post randomization. The trial was blinded, placebo-controlled, and all subjects received behavioral support for the duration of the trial. The primary endpoint was biochemically verified continuous abstinence during the last 4 weeks of treatment. Secondary outcome measures assessed continued abstinence rates through 6 months from the start of study treatment. The full manuscript is published in JAMA.

About Achieve and Cytisinicline
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.^1,2 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.²

In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.³ In 2022, approximately 2.5 million middle and high school students in the United States reported using e-cigarettes.⁴ Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States.