Late-stage pharmaceutical company Achieve Life Sciences Inc (Nasdaq:ACHV) announced on Wednesday that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to cytisinicline for nicotine e-cigarette, or vaping, cessation.

This designation is based on results from the Phase 2 ORCA-V1 trial, which showed that cytisinicline more than doubled the odds of quitting e-cigarettes compared to placebo.

Cytisinicline has the potential to be the first FDA-approved medication for nicotine vaping cessation.

Breakthrough Therapy Designation will expedite the development and review of cytisinicline. Achieve plans to hold an End-of-Phase 2 meeting with the FDA before the end of the year.