BOTANIX SB INC – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Botanix SB Inc. regarding its New Drug Application (NDA 217347) for sofpironium bromide, initially received September 23, 2022. Submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act, the application cannot be approved in its present form due to significant deficiencies. The primary concern is rooted in human factors, where the user interface of the proposed product does not support its safe and effective use. An evaluation of the human factors study revealed critical use errors and difficulties, including potential underdose, overdose, and inadvertent exposure, which carry risks such as local site reactions, blurred vision, and dry mouth. To resolve these issues, Botanix SB Inc. must conduct a thorough review of the human factors study results, implement specific design modifications (e.g., labeling the applicator, revising the instructions for use for clarity, adding a prominent hand-washing statement), and address foreseeable issues like gel spillage. Subsequently, a new human factors validation study is required to demonstrate the revised interface's safety and effectiveness. Additionally, the company must provide a comprehensive safety update, as outlined in 21 CFR 314.50(d)(5)(vi)(b), detailing any significant changes in the safety profile, new clinical data, and worldwide experience. Comments on prescribing information, carton/container labeling, and the proprietary name 'Sofdra' are reserved until these core deficiencies are fully addressed. Botanix SB Inc. has one year to resubmit a complete response.