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

Participants taking cytisinicline during the entire 12 weeks of study treatment showed successful quitting beyond 6 weeks of treatment. The probability of abstinence continued to increase after week 6 in participants who received 12 weeks of cytisinicline treatment, suggesting that continued new quitting attempts occurred and were successful among participants who had not achieved complete abstinence by week 6. These findings indicate that prolonged 12-week treatment for some people who smoke may be required to achieve successful abstinence.

Rates of abnormal dreams and insomnia occurred in less than 10% of each group, and rates of headache and nausea for cytisinicline were similar to placebo rates. Only 2.9% of subjects discontinued cytisinicline due to an adverse event and no drug-related serious adverse events occurred.

“We have not seen meaningful advancements in treatment options for people who smoke – and the doctors who care for them – for nearly two decades,” said Nancy Rigotti, MD, Professor of Medicine at Harvard Medical School Director, Tobacco Research and Treatment Center, Massachusetts General Hospital, and Principal Investigator of ORCA-2. “Currently available medications do not help all smokers to quit, and they produce unacceptable side effects in others. That is why, if approved by regulators, cytisinicline could offer a new option to treat smoking, the leading preventable cause of death worldwide.”

ORCA-2 was the first of two Phase 3 clinical trials to report positive outcomes for cytisinicline efficacy and safety. The Phase 3 ORCA-3 trial, for which results were reported in May 2023, also demonstrated statistically significant cessation rates for both 6- and 12-week cytisinicline and demonstrated that cytisinicline was very well-tolerated. Based on these data, Achieve expects to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cytisinicline as an aid in treating nicotine dependence for smoking cessation in adults trying to quit cigarette smoking in the first half of 2024. If approved, cytisinicline would be the first FDA-approved, prescription treatment for smoking cessation available in the United States in nearly two decades.