FDA CRL - B & B Pharmaceuticals, Inc.

The FDA issued a Complete Response Letter (CRL) to Defender Pharmaceuticals, Inc. for its New Drug Application (NDA 214315) concerning scopolamine nasal gel. The agency determined the application could not be approved due to significant human factors issues, product design deficiencies, and insufficient efficacy data. The primary concern was the device's user interface, which failed to support safe and effective administration. A human factors validation study revealed critical use errors, such as incorrect nozzle wiping or inappropriate dosing (e.g., multiple actuations in one nostril or a single actuation across both), potentially leading to higher-than-intended drug exposure. This was attributed to a conflict with the common mental model for nasal spray usage, where a single dose typically involves administration in both nostrils, contrasting with the intended single actuation in one nostril for this product. To address these deficiencies, Defender Pharmaceuticals must revise the user interface and device design to ensure safe and effective use, providing data to confirm these mitigations. The FDA recommends considering a dose adjustment to align with established user expectations. A redesigned interface and revised human factors validation study protocol must be submitted for agency review. Further requirements include a comprehensive safety update, revisions to prescribing information and carton/container labeling, and resubmission of the proprietary name. The FDA also indicated that the current clinical data are not sufficiently persuasive to demonstrate efficacy for preventing motion-induced nausea, recommending additional clinical trials.