Conclusions
1 evidence topic · 5 sources
Summary
Two placebo-controlled phase 3 trials demonstrated higher smoking-abstinence rates with cytisinicline plus behavioral support than with placebo plus behavioral support. The sponsor reported an FDA complete response letter citing manufacturing deficiencies and unfinished product labeling, without efficacy or clinical safety deficiencies, and anticipated potential approval in the first half of 2027. This remains an anticipated regulatory outcome, not an approval. Economic findings depend on an unannounced U.S. price.