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# Defender Pharma ‘Complete Response’ on Nausea Drug
- URL: https://www.fdaweb.com/defender-pharma-complete-response-on-nausea-drug/
- Published: 2024-01-30T12:00:00.000Z
- Updated: 2026-09-14T14:21:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156244

FDA has issued Defender Pharmaceuticals a complete response letter (CRL) on its NDA for intranasal scopolamine (DPI-386) for preventing nausea and vomiting induced by motion in adults. The company says it will request a formal meeting with FDA to “fully understand the issues raised in the CRL so we can develop and implement a comprehensive action plan.”

Defender says it has worked with the United States Naval Medical Research Unit and NASA on its intranasal scopolamine development program, which is focused on specific military personnel and astronauts. “To date, more than 1,300 patients have participated in Defender clinical studies, including over 500 participants in the DPI-386-MS-33 study,” it says.