Achieve Life Sciences reported that the US Food and Drug Administration issued a Complete Response Letter for the New Drug Application for cytisinicline, citing manufacturing-related observations at a third-party facility and incomplete product labeling. The agency identified no deficiencies related to the clinical efficacy or safety of cytisinicline.
Achieve said the Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) was related to observations made during an inspection of a former manufacturing facility, which had received an Official Action Indicated classification for general manufacturing compliance issues unrelated to cytisinicline.
Achieve previously disclosed that it expected to receive the CRL before its June 20, 2026, Prescription Drug User Fee Act action date and had partnered with Adare Pharma Solutions as its new primary commercial manufacturing partner. According to Achieve, work to establish manufacturing operations at Adare has included the transfer of analytical methods, production of a cytisinicline engineering batch, and qualification of testing procedures.
According to the company, the New Drug Application resubmission is expected in the fourth quarter of 2026 and will reflect Adare's role as the primary commercial manufacturing partner. Achieve stated that the resubmission could support potential FDA approval in the first half of 2027, followed by a US commercial launch.
Andrew D. Goldberg, MD, chief executive officer of Achieve Life Sciences, said, “The FDA's feedback provides a clear and actionable path forward.” He continued, “Our clinical data stands on its own: two successful Phase 3 trials and a robust open-label safety study.”
The New Drug Application is supported by a clinical development program in which more than 1,500 clinical trial participants were exposed to cytisinicline. In the Phase 3 ORCA-2 and ORCA-3 trials, cytisinicline administered for 6 or 12 weeks with standard behavioral support demonstrated greater smoking abstinence rates at the end of treatment and through week 24 compared with placebo.
Safety data include more than 400 participants who received at least 6 months of cumulative cytisinicline exposure and more than 200 participants who received at least 1 year of cumulative exposure. According to the company, the long-term safety findings were previously presented at the American Thoracic Society International Conference in May 2026.
Achieve is developing cytisinicline, a plant-derived compound, for smoking cessation and nicotine e-cigarette cessation. The company has completed a Phase 2 study in e-cigarette cessation and has received FDA Breakthrough Therapy designation for that indication.
Source: Achieve Life Sciences
