Defender gets CRL in response to its DPI-386 intranasal scopolamine NDA

Defender Pharmaceuticals announced that the FDA has issued a complete response letter in response to the NDA for DPI-386 scopolamine nasal gel that the company submitted in July 2023. The FDA accepted the NDA for review in September 2023, with a PDUFA goal date of January 26, 2024.

Defender President and CEO Barry I. Feinberg commented, “Following our review of the CRL, we plan on scheduling a formal meeting with the FDA to fully understand the issues raised in the CRL so we can develop and implement a comprehensive action plan. We remain confident that our intranasal scopolamine is a safe and effective therapy for the prevention of motion sickness, and we will work closely with the FDA to ensure that we can bring this innovative new product to the market.”

In October 2024, the company announced that the United States National Aeronautics and Space Administration (NASA) would conduct Phase 2 studies of DPI-386 in astronauts and other subjects during simulated and real spaceflight-associated activities that can cause motion sickness.

Read the Defender Pharmaceuticals press release.