Sarah Todd , 2025-04-30 08:30:00
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.
That would be a change of pace for the FDA, which public health experts have criticized for setting too high a bar for approving new smoking cessation drugs. Approval could open the door to more drug development in an area that addiction researchers say is sorely needed.
“Treatment for people with smoking issues and any type of addiction has to be individual-dependent,” said Olivier George, a professor at the University of California, San Diego, School of Medicine. People respond differently even to similar drugs, he said, so it’s important to have multiple options for smoking cessation treatments. “It would be very disappointing if it’s not approved.”
A modified version of a pill that’s been used as a smoking cessation drug in Eastern Europe for decades, cytisinicline partially blocks the nicotine receptors in the brain so smoking is less pleasurable and therefore easier to give up. Varenicline, originally marketed by Pfizer under the brand Chantix in 2006, works in much the same way. Both work much better than nicotine patches and lozenges, said George, himself a former smoker who quit with the help of varenicline. While nicotine patches and lozenges can help prevent withdrawal, they don’t blunt the appeal of cigarettes the way the drugs do, he said.
Research shows cytisinicline is highly effective in helping people quit. In a six-month Phase 3 trial published last week in JAMA Internal Medicine, 20.5% of people who took the pill were able to completely abstain from cigarettes from weeks 9-24 of the trial, compared to 4.2% of the placebo group.
“This medicine, when you compare it to placebo, is very effective in a wildly diverse group of smokers who have tried a lot of other things, including the other drugs on the market for smoking cessation,” said Nancy Rigotti, director of the Tobacco Research and Treatment Center at Massachusetts General Hospital. Rigotti co-authored the new study, which replicated the results of a Phase 3 trial of the drug published in 2023.
Research suggests cytisinicline may also be less likely to make people nauseous than varenicline, though George — who was not involved with the trials — said a larger study comparing the two drugs head-to-head is needed.
Pharmaceutical companies have shied away from developing new smoking cessation drugs in recent years for fear they might not have sufficient payoff. Further fueling the dearth of new drugs on the market is the FDA’s historically cautious approach, which has required companies to show their products help people abstain completely rather than reducing their use of cigarettes. The agency also unexpectedly asked Achieve to do a yearlong safety trial, delaying its drug approval submission.
But last October, FDA leaders held a public meeting on adopting a new regulatory approach to smoking cessation treatments and signaled a willingness to consider endpoints short of total abstinence. Stewart said that recent talks with the FDA have been promising, and that he expects the drug to be profitable. Achieve has a market cap of $84 million, and had $34 million in cash at the end of 2024.
Because varenicline is now available as a generic, the drug’s rollout would face little market competition, Stewart said. “If varenicline or Chantix did a billion dollars in revenues, we think we can absolutely get to that kind of level, and that with cigarette smoking only, not including vaping.” (The drug showed promise in a Phase 2 trial for vaping cessation last year.)
Achieve also has international ambitions for the drug, at which point Stewart said it would need to partner with a larger pharmaceutical company. He said the company plans to price the drug so it’s accessible to a wide range of people.
There are still unknowns about how the approval process will go, particularly in light of recent cuts at the FDA. “I hope that there will be an FDA group there to accept the new drug application when it goes in and evaluate it,” Rigotti said.
But she’s eager to see more alternative drugs to help smokers on the market. As a primary care physician, she said, it seems like there’s a new drug for diabetes or hypertension every week. “The medical community needs something to get excited about so that we do a better job working with our patients who smoke,” she said. “Our patients deserve another option.”
STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.
