ORCA-2 was designed to evaluate the efficacy and safety of 3mg cytisinicline dosed 3 times daily for a period of 6-weeks or 12-weeks compared to placebo in 810 adult smokers (randomized 1:1:1). Subjects were monitored for smoking abstinence for 24 weeks post randomization and received standard behavioral support for the duration of the trial.
Data Results
The primary endpoints for ORCA-2 were biochemically verified continuous abstinence measured during the last 4 weeks of treatment. Both the 6- and 12-week cytisinicline treatments demonstrated significantly better quit rates than placebo with odds ratios of 8.0 and 6.3, respectively.
Subjects who received 12 weeks of cytisinicline treatment had 6.3 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 9-12 was 32.6% for cytisinicline compared to 7.0% for placebo.
Subjects who received 6 weeks of cytisinicline treatment had 8 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 3-6 was 25.3% for cytisinicline compared to 4.4% for placebo.
Safety Profile
Well-tolerated with single digit rates of adverse events (AEs)
No treatment-related serious adverse events reported
Most commonly reported AEs (>5% Overall)
Low rates of AEs compares favorably to currently approved smoking cessation products
Design
- Placebo-controlled & double-blind
- 3 treatment arms: Placebo vs 6 or 12 weeks cytisinicline
Cytisinicline treatment for 6 or 12 weeks
- Does longer treatment lead to better efficacy?
- Does continued treatment prevent early relapses?
- Primary Endpoint: 4-week continuous abstinence ON treatment
- Follow up to 6 months
