FDA rejects Defender’s motion sickness treatment for astronauts
30 Jan 2024
Phase 3Clinical ResultDrug Approval
Defender Pharmaceuticals said Tuesday that the FDA declined to approve intranasal scopolamine (DPI-386), a motion sickness treatment intended for military personnel and astronauts.
In a statement, Defender CEO Barry Feinberg said the company plans “on scheduling a formal meeting with the FDA to fully understand the issues raised in the CRL (complete response letter),” but did not disclose what those issues were. The company did not respond to a request for comment from FirstWord.
Defender worked with NASA and the US Naval Medical Research Unit to develop the treatment – a nasal gel formulation of scopolamine, which has been approved since 1979 as a transdermal patch to treat motion sickness, according to the drug’s label. Scopolamine acts as a competitive inhibitor at cholinergic receptor sites of the parasympathetic nervous system.
The FDA submission included data from a Phase III trial which showed intranasal scopolamine met the primary endpoint of significantly reducing vomiting and the need for rescue treatment versus placebo.
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