New Report Calls Achieve Life's Cytisinicline Best Therapy To Quit Smoking
On Tuesday, Hunterbrook Media released a long report on Achieve Life Sciences Inc. (NASDAQ:ACHV), a roughly $250 million medical company. In June 2025, Achieve Life Sciences submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cytisinicline for nicotine dependence for smoking cessation in adults.
Cytisinicline could become the first FDA-approved smoking cessation therapy in nearly 20 years, with a U.S. launch expected in 2026.
According to the Hunterbrook report, cytisinicline is ‘likely the best therapy to quit smoking.’
In September, the U.S. Food and Drug Administration (FDA) accepted the cytisinicline New Drug Application (NDA), with a Prescription Drug User Fee Act (PDUFA) targeted action date of June 20, 2026.
Also, cytisinicline is under the FDA’s new Commissioner’s National Priority Voucher program for nicotine vaping addiction.
The report highlights that under the Affordable Care Act, most U.S. health plans are required to cover FDA-approved smoking-cessation therapies, creating a clear reimbursement pathway.
Cytisinicline is already widely used in Europe, and multiple smoking-cessation clinicians, researchers, and public-health leaders interviewed by Hunterbrook said the drug warrants FDA approval, with none calling for additional clinical data.
Cytisinicline has demonstrated a more favorable safety and efficacy profile than prior U.S. market leaders, including Pfizer Inc.’s (NYSE:PFE) Chantix (varenicline), which generated more than $1 billion in annual sales before being withdrawn, and GSK Plc’s (NYSE:GSK) Zyban (bupropion), which also exited branded markets but remains available in generic form.
The report noted that Chantix carried a suicidality warning and showed roughly four times higher nausea rates than cytisinicline, along with more sleep disturbances and headaches. The FDA later removed the suicidality warning from Chantix after further data.
Cytisinicline has not shown the risk of suicidal ideation.
Dr. Robert West of University College London told Hunterbrook that the FDA “definitely should” approve cytisinicline.
“From the available evidence, cytisinicline has the potential to be at least as effective as varenicline when given using an appropriate dosing regimen and is almost certainly more effective than bupropion,” West wrote to Hunterbrook.
ACHV Price Action: Achieve Life Sciences shares were up 7.42% at $4.76 at the time of publication on Tuesday, according to Benzinga Pro data.
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