FDA CRL - Sunovion Pharmaceuticals Inc.

The FDA issued a Complete Response Letter (CRL) to Sunovion Pharmaceuticals Inc. regarding its New Drug Application (NDA 210875) for Kynmobi (apomorphine) sublingual film, submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The agency determined it could not approve the application in its present form due to several critical deficiencies.

A primary issue concerned human factors. The human factors validation study for Kynmobi was deemed insufficient, identifying use errors and close calls on critical tasks, and failing to evaluate the final intend-to-market child-resistant packaging. The FDA expressed concern that Parkinson's patients, who may have dexterity impairments, could struggle to open the packaging, potentially delaying crucial therapy. Sunovion is required to conduct a new human factors validation study using the final packaging, evaluate observed errors, and implement additional mitigation strategies.

Further concerns included Clinical Pharmacology and Biopharmaceutics, requiring the completion and final report for Study CTH-203. The company must also clearly establish the scientific bridge between Kynmobi and the listed drug Apokyn, potentially via Apo-go. Lastly, the safety profile of Kynmobi necessitates further characterization, specifically regarding inadequately described oropharyngeal adverse events, which were reported in over 25% of Kynmobi-treated patients in a key study. Sunovion must address these points for reconsideration of their application.