Achieve life sciences, inc. announces presentation of cytisinicline data at society for research on nicotine & tobacco oceania (srnt-o) inaugural conference
Achieve life sciences, inc. announced that data from the phase 2b orca-1 trial will be presented at the srnt-o inaugural conference. orca-1 was designed to evaluate cytisinicline efficacy and safety across various dosing and administration schedules in 254 smokers in the united states. topline results, reported earlier this year, demonstrated a 54% abstinence rate at week 4 in the 3.0 mg three times daily (tid) cytisinicline arm compared to 16% for placebo (p < 0.0001). additionally for the 3.0 mg tid cytisinicline arm, a 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline was observed compared to 8% for placebo (p= 0.005). continuous abstinence for 4 weeks is the relevant endpoint for regulatory approval. overall adherence to study treatment was greater than 94% across all treatment arms and 98% in the 3.0 mg tid arm, specifically. cytisinicline was well-tolerated with no serious or severe adverse events (aes) reported. overall, in subjects treated with cytisinicline, all individual ae's reported were below a rate of 10%. minimal rates of abnormal dreams, insomnia, upper respiratory tract infections, and nausea were reported compared with placebo.
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