According to Defender Pharmaceuticals, the FDA has accepted the company’s NDA for DPI-386 scopolamine nasal gel for the treatment of motion sickness for priority review, with a PDUFA goal date of January 26, 2024. Defender submitted the NDA in July 2023. The company said that the FDA granted priority review at the request of the US Navy.
Defender President and CEO Barry I. Feinberg commented, “The acceptance of our first NDA is another critical milestone along the path of seeking commercial approval for a much needed, faster acting and practical treatment option for the debilitating symptoms induced by motion. Further, that the FDA has granted priority review status is a testament to the often under-recognized significance of preventing motion associated symptoms to ensure optimal operational performance during mission critical activities. We now look forward to active engagement and ongoing dialogue with the FDA as they conduct all aspects of their review. Defender is well underway in its planning for prospective commercialization of DPI-386 in the US and is poised to bring a much needed product to patients who have had to restrict their activities when exposed to motion in whatever manner.”
Read the Defender Pharmaceuticals press release.
