The FDA has accepted a new drug application (NDA) from Achieve Life Sciences for cytisinicline, a tablet to support smoking cessation.
Acceptance of the NDA was based on positive results from the phase 3 ORCA-2 and ORCA-3 trials. In the clinical trials, more than 2,000 participants received cytisinicline for either six or 12 weeks along with behavioral support. Compared to a placebo, the drug led to higher smoking abstinence both by the end of treatment and after 24 weeks. Safety data for the drug will consist of more than 400 participants who received cytisinicline for six months and more than 200 participants who received cytisinicline for at least 12 months.
Cytisinicline is an alkaloid derived from plants that has a high binding affinity to the nicotine acetylcholine receptor. It appears that, by interacting with receptors in the brain, cytisinicline lowers cravings and decreases the sense of satisfaction gained from nicotine.
The PDUFA targeted action date for cytisinicline is June 20, 2026. If the application is successful, cytisinicline will become the first pharmacotherapy approved by the FDA in two decades.
Achieve Life Sciences is a late-stage specialty pharmaceutical company that develops and commercializes cytisinicline to treat nicotine dependence. In addition to its ORCA-2 and ORCA-3 phase 3 trials, it has completed a phase 2 trial testing the potential of ORCA-2 and ORCA-3 trials for vaping cessation.