The First New Quit-Smoking Drug in Two Decades Is Ten Days from an FDA Decision

The FDA has until June 20 to decide whether to approve cytisinicline — a plant-derived alkaloid that, if it clears review, will be the first new smoking cessation medication in approximately twenty years. The last was varenicline, better known as Chantix, which launched in 2006 and was voluntarily withdrawn in 2021 after the FDA added its strongest safety warning over neuropsychiatric side effects. The gap since has not been good for the roughly 34 million Americans who still smoke, and it has been particularly bad for the people who are trying to do it while also managing recovery from another substance use disorder.

Cytisinicline, developed by Achieve Life Sciences, is extracted from the laburnum tree (Cytisus laburnum) and has been prescribed for smoking cessation in Eastern European countries since the 1960s — decades before any American clinician had heard of it, and largely without the psychiatric safety signals that ended Chantix. Both drugs act as partial agonists at the α4β2 nicotinic acetylcholine receptor, the principal target through which nicotine delivers its rewarding and addictive effects. By binding to that receptor, they reduce nicotine craving and diminish the reward obtained from actually smoking — making the cigarette feel like less, and making the absence of it feel like less.

The FDA accepted Achieve’s New Drug Application in 2025 and set a PDUFA target date of June 20, 2026. The application rests on data from two Phase 3 trials — ORCA-2 and ORCA-3 — enrolling more than 2,000 adult smokers combined. Both trials showed cytisinicline significantly improved continuous smoking abstinence rates compared to placebo at 24 weeks, a rigorous endpoint. Achieve also received an FDA Commissioner’s National Priority Voucher for cytisinicline’s potential in e-cigarette and vaping cessation — a nicotine dependence category with zero FDA-approved treatments and a large and growing patient population.

Why this matters in addiction medicine specifically: tobacco is the most common comorbidity in every other substance use disorder. Smoking rates among people in treatment for alcohol, opioid, or stimulant use disorder run two to four times higher than in the general population. Tobacco-related disease — cardiovascular disease, COPD, cancer — is the leading cause of death among people in long-term recovery, killing more people in recovery communities than relapse does.

Nicotine dependence tends to get treated as the acceptable addiction — the one vice left after the harder work is done. That framing has real costs. Treatment programs that focus exclusively on the primary presenting substance often don’t address tobacco at all, and many recovery communities have normalized smoking in ways that create barriers to cessation. A new pharmacological tool — particularly one with a decades-long European safety record — could shift that conversation.

The June 20 decision will not transform the treatment landscape overnight. Prescribing patterns change slowly. Insurance formulary decisions take months after approval. The neuropsychiatric safety question — whether cytisinicline carries any of the risks that ended Chantix — is a focus of FDA review, though post-marketing surveillance data from Eastern Europe is reassuring. But for the clinician sitting across from a person in recovery who has quit heroin and can’t quit cigarettes, a new option in the toolkit matters.