FDA rejects Defender’s motion sickness treatment

The FDA has rejected Defender Pharmaceuticals' intranasal scopolamine gel, DPI-396, for the prevention of nausea and vomiting induced by motion sickness. The decision was communicated through a Complete Response Letter (CRL) sent to the company. Despite promising results from clinical trials, which include a Phase 3 study with over 500 participants, Defender's formulation was not approved by the FDA.

Defender's intranasal scopolamine gel is a smaller and more concentrated dose designed for rapid absorption, supporting the potential benefits of rapid onset of action. The related concerns or reasons for the FDA's rejection are not detailed in the available search results but might include safety, efficacy, or manufacturing concerns.

Scopolamine, the active ingredient in the gel, is already approved by the FDA as a transdermal system for treating motion sickness and postoperative nausea and vomiting. The decision to reject Defender's nasal gel formulation can be interpreted as a step toward ensuring that new drugs meet the FDA's standards for safety and efficacy before being introduced to the market.

Defender Pharmaceuticals, a privately held St. Louis company, remains confident in the safety and effectiveness of their intranasal scopolamine formulation and has planned to meet with the FDA to better understand the issues raised in the CRL and develop an action plan to address the FDA's concerns.