{"id":7317,"date":"2024-01-31T19:21:23","date_gmt":"2024-02-01T00:21:23","guid":{"rendered":"https:\/\/lifescivoice.com\/?p=7317"},"modified":"2024-01-31T19:21:55","modified_gmt":"2024-02-01T00:21:55","slug":"defender-pharmaceuticals-confronts-fda-setback-in-approval-journey-for-nasal-motion-sickness-gel","status":"publish","type":"post","link":"https:\/\/lifescivoice.com\/defender-pharmaceuticals-confronts-fda-setback-in-approval-journey-for-nasal-motion-sickness-gel\/","title":{"rendered":"Defender Pharmaceuticals Confronts FDA Setback in Approval Journey for Nasal Motion Sickness Gel"},"content":{"rendered":"\n<p>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&#8217;s CEO, Barry Feinberg, to announce plans for a meeting to understand CRL concerns and devise a comprehensive action plan.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script>\n<ins class=\"adsbygoogle\" style=\"display:block; text-align:center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins>\n<script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script>\n\n\n\n<p>Novartis received FDA approval for a scopolamine patch in 2012, mainly for air or sea travel and postoperative nausea prevention. However, Defender&#8217;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.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<p>In addition to motion sickness, Defender envisions potential applications for DPI-396 in addressing depression and preventing motion sickness linked to virtual reality goggles.<\/p>\n\n\n\n<p>Scopolamine, a recognized anticholinergic compound, mimics the neurotransmitter acetylcholine, targeting the parasympathetic nervous system. Defender&#8217;s website notes its efficacy in addressing motion sickness symptoms, major depressive disorder, and virtual reality sickness.<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script>\n<ins class=\"adsbygoogle\" style=\"display:block; text-align:center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins>\n<script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script>\n\n\n\n<p>In September 2023, the FDA accepted Defender&#8217;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&#8217;s effectiveness in reducing vomiting, rescue medication need, and moderate-severe nausea after ocean vessel travel.<\/p>\n\n\n\n<p>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.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>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&#8217;s CEO, Barry Feinberg, to announce plans for a meeting to understand CRL concerns and devise a comprehensive action [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":7318,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[],"class_list":{"0":"post-7317","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-regulatory"},"_links":{"self":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/7317","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/comments?post=7317"}],"version-history":[{"count":1,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/7317\/revisions"}],"predecessor-version":[{"id":7319,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/7317\/revisions\/7319"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media\/7318"}],"wp:attachment":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media?parent=7317"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/categories?post=7317"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/tags?post=7317"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}