NASA and Defender Pharmaceuticals will test an anti-nausea gel in two clinical trials, recruiting astronauts to undergo motion simulation exercises to test sensorimotor performance.
The two partners are collaborating on the phase 2 clinical trial of the St. Louis-based drugmaker’s anti-nausea gel that targets motion sickness and enhances sensorimotor performance such as keeping balance and executing fine motor skills like writing and other movements.
The first of the trials for Defender’s DPI-386 (intranasal scopolamine gel) is a randomized, double-blind, placebo-controlled, crossover investigation that compares motion sickness symptom severity and time to severe malaise in 30 subjects, age 18 to 65, who will be exposed to simulated wave motion on a platform inside of a crew capsule mock-up, the company said in an Oct. 24 press release.
The second portion of the trials will take place in field settings for about 80 astronaut and ground-control subjects who will be exposed to “provocative motion" as part of their assigned duties. Examples include motion simulations, parabolic flights or Orion capsule recovery operations. The subjects will be recruited from free-flyer missions such as SpaceX, Inspiration4, Polaris Dawn, private astronaut missions such as Axiom or standard International Space Station missions.
“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,” Dave Helton, Defender’s chief scientific officer, said in a release.
The company, which recently reeled in $70 million in financing, has submitted a new drug application to the FDA for DPI-386 nasal gel for the prevention of nausea and vomiting induced by motion.