Defender Pharmaceuticals Confronts FDA Setback in Approval Journey for Nasal Motion Sickness Gel

Defender Pharmaceuticals, headquartered in St. Louis, faces a setback in its quest for FDA approval for their nasal gel, DPI-396, designed to prevent motion-induced nausea and vomiting. The FDA issued a complete response letter (CRL), prompting Defender’s CEO, Barry Feinberg, to announce plans for a meeting to understand CRL concerns and devise a comprehensive action plan.

In 2012, NASA collaborated with Epiomed Therapeutics to create a nasal spray version of scopolamine, targeting motion sickness in astronauts. Defender acquired Epiomed in 2014, and the U.S. Naval Medical Research Unit was also involved in DPI-396 development. If approved, Defender plans to initially offer the treatment to the military before a broader market release.

Novartis received FDA approval for a scopolamine patch in 2012, mainly for air or sea travel and postoperative nausea prevention. However, Defender’s intranasal formulation, with a more concentrated, rapidly absorbed dose, proved effective in a phase 3 study with over 500 participants experiencing motion on an ocean trip.

While the patch induces drowsiness lasting for days, DPI-396 demonstrated reduced vomiting and nausea compared to a placebo. Defender and NASA are conducting a phase 2 trial with astronauts undergoing motion simulation exercises to assess motor skills and balance while avoiding nausea.

In addition to motion sickness, Defender envisions potential applications for DPI-396 in addressing depression and preventing motion sickness linked to virtual reality goggles.

Scopolamine, a recognized anticholinergic compound, mimics the neurotransmitter acetylcholine, targeting the parasympathetic nervous system. Defender’s website notes its efficacy in addressing motion sickness symptoms, major depressive disorder, and virtual reality sickness.

Scopolamine received FDA approval in 1979 and is currently administered through a patch behind the ear. Defender proposes an intranasal gel formulation, developed in collaboration with the U.S. Naval Medical Research Unit and NASA, with a focus on military personnel and astronauts whose performance can be significantly affected by motion sickness.

In September 2023, the FDA accepted Defender’s NDA for the intranasal gel formulation, supported by data from over 1,300 patients participating in the clinical program. In June 2023, Defender released data from the pivotal Phase III DPI-386-MS-33 study, demonstrating the investigational formulation’s effectiveness in reducing vomiting, rescue medication need, and moderate-severe nausea after ocean vessel travel.

Beyond motion sickness, Defender is exploring applications for its intranasal scopolamine formulation in major depressive disorder with suicidal ideation, chemical exposure, traumatic brain injury, and virtual reality sickness.

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