Clinical Efficacy And SafetyConsistent positive outcomes from ORCA-2 and ORCA-3 trials, along with decades of international use, support a favorable efficacy and safety profile that strengthens the case for approval and clinician confidence.
First-to-market Commercial OpportunityPotential to be the first approved prescription therapy for nicotine vaping cessation and targeted label expansion could enable meaningful penetration of an underserved cessation market with focused promotion.
Regulatory AccelerationAward of an FDA Commissioner's National Priority Voucher combined with Breakthrough Therapy designation could accelerate review interactions and shorten the path to approval for a vaping cessation indication.