St. Louis-based Defender Pharmaceuticals revealed that the U.S. FDA issued a complete response letter in response to the company’s NDA for intranasal scopolamine for the prevention of nausea and vomiting induced by motion.
While Defender did not share the reasons why the agency rejected the application, the company said it plans to schedule a formal meeting with the FDA to fully understand the issues raised in the CRL and implement an action plan.
Scopolamine has been approved for decades as a transdermal system for the treatment of motion sickness and postoperative nausea/vomiting. According to Defender, when administered as an intranasal gel, scopolamine demonstrated rapid absorption, which means the formulation could potentially bring relief faster.
The gel, Defender's lead program, is intended for specific military personnel and astronauts. The company has been working with the U.S. Naval Medical Research Unit and NASA on the development.