(RTTNews) - Achieve Life Sciences, Inc. (ACHV), a late-stage specialty pharmaceutical company, on Monday announced a positive outcome of the second independent review by the Data Safety Monitoring Committee or DSMC for its ongoing ORCA-OL clinical trial.
The trial evaluates the long-term safety of cytisinicline, a novel treatment for smoking cessation and nicotine dependence.
Preliminary findings from the DSMC show no unexpected adverse events related to the treatment, and participants exhibited excellent adherence to the medication regimen.
Safety data from this review aligns with previous findings, confirming the treatment's safety profile.
This positive assessment allows the trial to proceed without any changes, keeping Achieve Life Sciences on track for its New Drug Application or NDA submission for cytisinicline in the second quarter 2025.
The ORCA-OL trial, which has enrolled 479 participants at 29 clinical sites across the U.S., is designed to meet the FDA's long-term exposure safety data requirements for the potential approval of cytisinicline.
With this encouraging data, Achieve Life Sciences is closer to its goal of providing a new treatment option for individuals suffering from nicotine dependence.
ACHV closed Friday's (Feb.07 2025) trading at $3.05 down 4.98%. In premarket trading Monday, the stock is up by 4.59% at $3.19.
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