(RTTNews) - 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 initiated in the third quarter of 2025.
Meanwhile, the company is planning to submit a New Drug Application to the FDA for approval of cytisinicline as an aid in treating nicotine dependence for smoking cessation in the second quarter of 2025.
Currently, ACHV is trading at $4.40, up by 0.46 percent on Nasdaq.
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