PhIII win for smoking cessation treatment puts Achieve Life Sciences on path to FDA, jazzes up deal talks
A specialty pharma out to bring a smoking cessation treatment long used in Central and Eastern Europe to the US says it’s cleared the final hurdle before filing with the FDA.
Achieve Life Sciences, which is based in Seattle and Vancouver, said its candidate, cytisinicline, met the primary and secondary endpoints in a confirmatory Phase III trial, more than a year after it announced a win for its first Phase III trial. With both six- and 12-week treatment cycles, the drug improved the odds that study participants could quit smoking — and stay abstinent.
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