Defender Pharmaceuticals announced that it has submitted an NDA for its DPI-386 scopolamine nasal gel for the prevention of motion sickness in adults. According to the company’s web site, Defender has worked with the US Navy and with the National Aeronautics and Space Administration (NASA) on development of DPI-386. Epiomed Therapeutics, which was founded by Defender’s Chief Scientific Officer David R. Helton, announced a deal with NASA to develop intranasal scopolamine in 2012.
According to Defender, a recent Phase 3 study of the nasal gel met its primary endpoint, demonstrating a significant reduction in the proportion of participants who did not report vomiting within 4 hours for those who used DPI-386 compared to those who received a placebo. The company said that participants also reported a statistically significant reduction in moderate-to-severe nausea for the nasal gel compared to placebo.
Defender President and CEO Barry I. Feinberg commented, “The submission of our first NDA is a key milestone for Defender and positions the company well for a product launch in a market with substantial need of more effective treatment options. The submission of our NDA, with such a robust body of supportive efficacy and safety data, brings us one critical step closer to that goal. We look forward to working closely with the FDA during its review process.”
Read the Defender Pharmaceuticals press release.
