- Achieve Life Sciences (ACHV, Financial) wraps up ORCA-3 Phase 3 trial, showcasing cytisinicline's efficacy in smoking cessation.
- Trial results published in JAMA Internal Medicine, endorsing cytisinicline's clinical potential.
- Company plans to submit a New Drug Application (NDA) to the FDA by June 2025.
Achieve Life Sciences (ACHV) has announced the successful completion of its ORCA-3 Phase 3 clinical trial, with results published in the prestigious Journal of the American Medical Association (JAMA) Internal Medicine. This study evaluated the efficacy of cytisinicline, a novel treatment aimed at aiding smoking cessation.
The trial involved 792 U.S. adults, who were administered cytisinicline over six and twelve-week treatment durations. Results indicated significant improvements in smoking cessation rates and reduced nicotine cravings, benefits that persisted through 24 weeks. The participants, averaging 53 years of age and with a long-term smoking history, demonstrated effective cessation with significantly reduced cravings.
Cytisinicline's mechanism of selective targeting of nicotine receptors appears to offer an improved tolerability profile compared to existing treatments, reducing common adverse effects like nausea. These findings contribute valuable data to Achieve Life Sciences' planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in June 2025.
The ORCA-3 trial results present cytisinicline as a promising candidate in addressing the significant public health challenge posed by smoking, which remains the leading cause of preventable death in the United States. Dr. Nancy Rigotti from Harvard Medical School has endorsed the study, highlighting its potential impact on public health if approved by the FDA.
