Researchers at the United States National Aeronautics and Space Administration (NASA) will lead 2 Phase 2 studies of Defender Pharmaceuticals’ DPI-386 scopolamine nasal gel for the prevention of motion sickness induced by sudden changes in gravitoinertial forces (g-transitions) such as those experienced by astronauts. The FDA recently accepted Defender’s NDA for DPI-386 for the treatment of motion sickness and granted priority review at the request of the US Navy.
According to Defender, one of the studies will enroll 30 adult subjects and will evaluate the efficacy of self-administered DPI-386 with and without sensory augmentation versus placebo as subjects experience simulated wave motion while inside a mockup of a crew capsule. The other study will enroll about 80 astronauts and ground-control subjects who will use DPI-386 during activities such as parabolic flights, launch, landing, or capsule recovery. Astronauts will be recruited from both NASA missions and private spaceflight missions.
Defender Chief Scientific Officer Dave Helton commented, “Positive results from either or both of these clinical studies will bolster the growing body of data supporting the use of DPI-386 to prevent the symptoms associated with motion while also potentially expanding the breadth of applications for which intranasal scopolamine gel can serve this purpose. We are excited and eager to get enrollment in these studies underway as soon as possible, in anticipation of results in second quarter 2024.”
Read the Defender Pharmaceuticals press release.
