Clinical Trial ResultsCytisinicline 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 OpportunityLabel expansion focused on e-cigarette cessation represents a unique commercial opportunity that will substantially boost cytisinicline's use in key markets.
Regulatory ApprovalAchieve 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.