India, Dec. 3 -- Achieve Life Sciences Inc. (ACHV), a late-stage pharmaceutical company, today, announced a successful End-of-Phase 2 meeting with the FDA to advance Cytisinicline as a potential first-in-class treatment for e-cigarette or vaping cessation.
The End-of-Phase 2 meeting paved the way for the company to obtain FDA agreement on the proposed single Phase 3 study design for cytisinicline treatment in vaping cessation and on the additional requirements for submitting a supplemental new drug application (sNDA) to expand cytisinicline for the treatment for vaping cessation.
The proposed Phase 3 trial, dubbed ORCA-V2, will assess the efficacy and safety of cytisinicline for nicotine e-cigarette cessation and is expected to be initiat...