FDA rejects Achieve smoking drug over manufacturing, not efficacy concerns

The FDA declined to approve Achieve Life Sciences’ smoking-cessation drug cytisinicline because of unresolved manufacturing issues, not because the treatment fell short on efficacy or safety. Achieve said the complete response letter cited deficiencies at a prior third-party manufacturing facility and did not identify clinical safety or effectiveness problems.

The company had expected the letter on or before its June 20, 2026, PDUFA date. In a June 22 press release, Achieve said the labeling was not complete by the agency’s action date and that it had already partnered with Adare Pharma Solutions, a U.S.-based company, as its new primary commercial manufacturing partner. Achieve said it plans to resubmit the new drug application in the fourth quarter of 2026 and said approval could come in the first half of 2027.

Cytisinicline is a plant-derived compound designed to reduce cravings and withdrawal symptoms by targeting nicotine receptors in the brain. The U.S. market for quit-smoking medicine remains narrow, with prescription options still centered on Pfizer’s Chantix, GSK’s Zyban, and nicotine replacement products. CDC materials list seven FDA-approved medicines to help adults quit cigarettes, including nicotine patch, lozenge, gum, oral inhaler, nasal spray, varenicline and bupropion SR.

Smoking-cessation products can help people quit and may double the chances of success. Achieve has said cytisinicline, if approved, would be the first new FDA-approved smoking-cessation treatment in 20 years.

ORCA-3, published in JAMA Internal Medicine in 2025, studied 792 adults who smoked at least 10 cigarettes a day and found that cytisinicline increased smoking abstinence and reduced nicotine craving versus placebo.