Achieve Life Sciences Inc. (NASDAQ:ACHV) on Monday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application seeking approval of cytisinicline, its investigational treatment for nicotine dependence.
The company said the FDA’s concerns were tied to manufacturing-related issues at a former third-party facility and incomplete final product labeling, while no deficiencies were identified regarding the drug’s safety or efficacy.
In March, the company reported that the FDA inspected one manufacturer named in the cytisinicline application and identified two observations related to solid oral dose manufacturing.
FDA Cites Manufacturing Issues At Former Third-Party Facility
According to the company, the CRL stems from observations made during a current Good Manufacturing Practice inspection at a previous third-party manufacturing site.
The facility received an Official Action Indicated classification from the FDA for general cGMP issues that were not specific to cytisinicline. Achieve had previously disclosed that it expected to receive a CRL before June 20, 2026.
The FDA also noted that final product labeling had not been completed by the agency before the review deadline.
Company Shifts Manufacturing To Adare Pharma Solutions
Achieve said it had already taken steps to address the manufacturing concerns by selecting U.S.-based Adare Pharma Solutions as its new primary commercial manufacturing partner.
The company said it has completed the analytical method technology transfer to Adare’s facility, produced its first cytisinicline engineering batch, and fully qualified all testing procedures at the site.
Achieve plans to resubmit the NDA in the fourth quarter of 2026, naming Adare as its primary manufacturing partner. If approved, the company expects potential FDA approval in the first half of 2027, followed by a U.S. commercial launch.
CEO Says Clinical Data Remains Strong
“The FDA’s feedback provides a clear and actionable path forward,” said Andrew D. Goldberg, CEO of Achieve.
Goldberg highlighted that cytisinicline’s clinical package includes two successful Phase 3 studies and an extensive open-label safety study, adding that the company remains focused on both resolving the remaining regulatory requirements and preparing for commercialization.
The NDA is supported by a clinical development program involving more than 1,500 participants exposed to cytisinicline.
In the pivotal Phase 3 ORCA-2 and ORCA-3 trials, cytisinicline, administered for six or 12 weeks alongside behavioral support, demonstrated significantly higher smoking abstinence rates through the end of treatment and sustained abstinence through week 24 compared with placebo.
Long-term safety data included more than 400 participants with at least six months of cumulative exposure and more than 200 participants with at least one year of exposure, results that were previously presented at the American Thoracic Society International Conference in May 2026.
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