Will the FDA approve the first new drug to help people quit smoking in 20 years?

Nearly 12% of Americans still smoke cigarettes, the leading cause of preventable death nationwide. Yet there are only two medications authorized by the Food and Drug Administration to help them quit — the more effective of which, varenicline, can come with unsavory side effects like nausea that make people less likely to stick with treatment.

A new pill with fewer side effects could soon be available from the Washington state-based biotech Achieve Life Sciences. The company plans to file for FDA approval of its drug, called cytisinicline, in June. 

Rick Stewart, Achieve’s co-founder and CEO, told STAT that he expects the drug to be approved in mid-2026 and to launch in the U.S. by the end of that year. “This will be the first new drug for nicotine dependence in nearly 20 years,” he said. 

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