- 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.
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