Achieve Life Sciences To Start Cytisinicline's Trial For Nicotine E-cigarette Cessation

The FDA has signed off Achieve Life Sciences Inc's ACHV Investigational New Drug (IND) application to investigate cytisinicline as a cessation treatment for nicotine e-cigarette users.
In addition to the ongoing Phase 3 program for cytisinicline treatment in combustible cigarette cessation, the Company expects to initiate the ORCA-V1 e-cigarette and vape cessation trial in Q2 of 2022.
The Phase 2 ORCA-V1 study will enroll approximately 150 adult nicotine e-cigarette users.
Grant funding to support the trial has been awarded in two phases from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH).
Achieve recently announced completion of enrollment in Phase 3 ORCA-2 trial, evaluating cytisinicline as a treatment for combustible cigarette cessation. Topline results from the ORCA-2 trial are expected in 1H of 2022.
Related content: Benzinga's Full FDA Calendar.
Price Action: ACHV shares are down 2.99% at $8.11 during the market session on the last check Tuesday.