• by Les Luchter , Staff Writer, July 24, 2025

America’s fight against nicotine addiction may be waning under the Trump Administration.

A three-decades-old ban on using federal funds to promote the sale or export of tobacco or tobacco products around the world was recently left out of an appropriations bill passed by a U.S. House of Representatives subcommittee. If that bill becomes law, it “would open the door for the tobacco industry to leverage the State Department and U.S. embassies to subvert lifesaving tobacco control efforts,” warns the Campaign for Tobacco-Free Kids.

That nonprofit also joined 86 other organizations a couple of months ago in a letter to Health & Human Services (HHS) Secretary Robert F. Kennedy Jr. protesting cutbacks at both the Centers for Disease Control’s Office on Smoking and Health and the Food and Drug Administration's Center for Tobacco Products.

HHS had previously tabbed tobacco use as the leading cause of preventable death in the U.S., responsible for more than half a million deaths annually.

Meanwhile, 29 million people in the U.S. continue to smoke cigarettes, according to the latest CDC statistics from 2022. In that same year, 67.7% of those smokers said they wanted to quit, 53.3% of them had tried to quit during the previous year -- but less than 10% of smokers succeed in quitting annually. 

Amid all the smoke, we’re happy to report a ray of light: Startup pharma firm Achieve Life Sciences last month applied to the FDA for approval of smoking cessation drug cytisinicline, which in phase 3 trials showed a 30.3% effective rate after treatment, compared with 9.4% for a placebo.

FDA approval is expected as early as the third quarter next year, Achieve’s Chief Commercial Officer Jaime Xinos tells Pharma & Health Insider. That would mark 20 years since the last such drug came to market: Pfizer’s Chantix, now available generically as varenicline.

Unsuccessful varenicline users will be a key target for the still-unnamed branded version of cytisinicline, Xinos says. “We’re looking at patients who are already having very active conversations with their physicians about quitting, who have likely tried multiple modalities in the past.”

Cytisinicline is also more tolerable than alternatives, she says, with fewer side effects like nausea, “which cause early discontinuation or patients to refuse therapy altogether.”

In addition to the 29 million Americans who smoke, Xinos says another 17 million people vape, and “what we’ve tried to do is identify which patients would be most likely to make an aggressive, highly motivated attempt” to quit.

Helping to garner those customers will be Omnicom, which has already been working with Achieve for three years on identifying the new drug’s target audience, brand strategy and positioning.

Michael Collins, president, health & wellness for the Omnicom Advertising Collective, tells Pharma & Health Insider that agencies getting involved in marketing and brand strategy during clinical development is not at all unusual, but “what’s unique about Achieve has been their ask of us to be on the journey with them as they’ve explored and developed through launch and beyond.”

Omnicom’s work has included participation in clinical trials, Xinos notes. With cravings and withdrawal symptoms being key reasons why smoking cessation often fails, she says, research from Omnicom helped “show that our product reduces those key concerns for patients.”

“A lot of the research that we’ve done with people who are trying to quit [shows] they are incredibly frustrated,” Xinos adds. “They take it very personally that their attempts have been failures.”

She continues: “We’re giving them hope, so I think you’ll see that come through in our campaigns. It's not just because there’s another medicine. It’s another reason to try again and to build the confidence that this time, you will be successful. We really want to convey that.”

Collins adds that, in reaching both consumers and healthcare professionals, an awareness campaign about the health problem itself isn’t as much of a need as with other new drugs  “Smoking and its deleterious effects down the line are such a well-known issue from a medical standpoint,” he says, so the marketing is likely to be more about the “innovation in the space.”

So a pre-launch HCP awareness campaign would likely focus on the fact that something new is coming in the cessation category, says Collins.