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Seattle biotech Achieve Life Sciences on Tuesday announced an experimental drug meant to help people quit smoking did exactly that in a clinical trial, paving the way for the company to seek approval for a product that would face stiff competition.

In the study, dubbed ORCA-3, participants took either the smoking cessation drug cytisinicline or a placebo pill three times a day for six or 12 weeks. About 30% of those on a 12-week course of cytisinicline went the last month of treatment without smoking, compared to 9.4% of participants in the placebo group. And nearly 15% of smokers on a six-week course of cytisinicline quit during the last month of treatment, compared to 6% of those on placebo. Both of these differences were statistically significant, and the drug’s side effects were relatively mild.


It’s the second time the company has reported Phase 3 trial results showing that cytisinicline helps smokers quit without triggering major side effects. The company next plans to apply for Food and Drug Administration approval by the first half of 2024, according to CEO John Bencich.

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