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FDA Rejects Smoking Cessation Drug
22 Jun
Summary
- FDA declined approval due to manufacturing and labeling issues.
- No clinical efficacy or safety concerns were cited by the FDA.
- Achieve plans to resubmit its application in late 2026.
The U.S. Food and Drug Administration (FDA) has declined to approve Achieve Life Sciences' experimental drug, cytisinicline, intended to help adults quit smoking. This decision, issued on June 22, 2026, was due to unresolved issues identified at a third-party manufacturing facility and incomplete final product labeling by the agency's action date.
Despite the setback, the FDA's complete response letter indicated no deficiencies related to cytisinicline's clinical efficacy or safety. Achieve Life Sciences views this absence of clinical concerns as a positive sign for future approvability.
The company is now manufacturing the drug through U.S.-based Adare Pharma Solutions and aims to resubmit its application in the fourth quarter of 2026. Potential FDA approval for cytisinicline is anticipated in the first half of 2027.
Cytisinicline, a plant-derived compound, targets nicotine receptors in the brain to reduce cravings and withdrawal symptoms without delivering nicotine. Late-stage trials involving over 1,500 participants demonstrated that cytisinicline was more effective than a placebo in helping adults quit smoking.
