Clinical Trial SuccessCytisinicline demonstrated positive results in the P3 ORCA-2 study, achieving significant rates of smoking cessation compared to placebo without serious treatment-related adverse events.
Market PotentialCytisinicline is expected to be the first FDA-approved drug for smoking cessation in 20 years, highlighting its potential to fill a significant gap in the market.
Regulatory AdvancementsAchieve Life Sciences received an FDA Commissioner's National Priority Voucher for cytisinicline in e-cig/vaping cessation, allowing for expedited FDA review and potential earlier market entry.