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# FDA Accepts NDA for Smoking Cessation Drug
- URL: https://www.fdaweb.com/fda-accepts-nda-for-smoking-cessation-drug/
- Published: 2025-09-03T12:00:00.000Z
- Updated: 2026-09-14T15:20:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159805

FDA has accepted for review an Achieve Life Sciences’ NDA for cytisinicline, an investigational treatment for nicotine dependence. The submission has been assigned a user fee review action target date of 6/20/2026.

The NDA is based on data from more than 2,000 clinical trial participants enrolled in the company’s Phase 3 ORCA-2 and ORCA-3 studies. Data showed that cytisinicline, taken for six or 12 weeks alongside behavioral support, led to significantly higher smoking abstinence rates compared to placebo through 24 weeks, according to the company, adding that there were no new safety issues identified.

Cytisinicline is described by the company as a plant-derived alkaloid that works by binding to nicotine receptors in the brain to reduce cravings and blunt the reward associated with nicotine.