Achieve Life Sciences (ACHV) announced that the Data Safety Monitoring Committee, DSMC, has recently completed its second independent review of the ongoing ORCA-OL trial, evaluating long-term exposure of the novel 3 mg cytisinicline treatment dosing regimen in individuals who smoke cigarettes or vape nicotine. Following this second comprehensive review of available safety data, the DSMC stated that it did not identify any unexpected treatment-related adverse events and that the participants’ adherence to their cytisinicline medication was excellent. Overall safety data remains consistent with previous findings. The DSMC concluded the study may continue as planned without any modifications.
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