FDA Accepts Defender Pharmaceuticals’ New Drug Application for Intranasal Scopolamine Gel

  • PDUFA date of January 26th, 2024
  • Assigned Priority Review Status at the Request of the US Navy
  • Submission based on five Phase III clinical trials, including overwhelmingly positive results from the -33 Phase 3 study

ST. LOUIS, MO—(BUSINESS WIRE)—September Sep. 26, 23—Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) submission for intranasally administered scopolamine gel (DPI-386 Nasal Gel). The FDA has granted priority review status for the NDA, at the request of the U.S. Navy, and the Prescription Drug User Fee Act (PDUFA) action date, by when the FDA is anticipated to render a decision on the submission, is set for January 26th, 2024.

“The acceptance of our first NDA is another critical milestone along the path of seeking commercial approval for a much needed, faster acting and practical treatment option for the debilitating symptoms induced by motion,” said Barry I. Feinberg, M.D., President & CEO of Defender Pharmaceuticals. “Further, that the FDA has granted Priority Review status is a testament to the often underrecognized significance of preventing motion associated symptoms to ensure optimal operational performance during mission critical activities. We now look forward to active engagement and ongoing dialogue with the FDA as they conduct all aspects of their review.  Defender is well-underway in its planning for prospective commercialization of DPI-386 in the U.S. and is poised to bring a much-needed product to patients who have had to restrict their activities when exposed to motion in whatever manner.”

The NDA submission was based on a multi-study clinical development program, including overwhelmingly positive results from the Company’s most recently completed Phase 3 study of DPI-386 Nasal Gel (the —33 study).

The Company recently announced that results from the -33 study trial results were presented at the 2023 Military Health System Research Symposium (MHSRS) in Kissimmee, FL. Details on the presentation can be found on the Company’s website at https://defenderpharma.com/.

About Defender Pharmaceuticals, Inc.
Defender Pharmaceuticals, Inc., located in St. Louis, MO, is a privately held life sciences company focused on discovering, developing and commercializing medicines to help safeguard health across civilian and military populations. Our work with the Department of Defense, NASA, the Department of Veterans Affairs, and other institutions advance our mission to improve the health of patients and help make the world a more secure place.

About Intranasal Scopolamine
In pharmacokinetic studies in healthy volunteers, scopolamine administered via an intranasal gel demonstrated rapid absorption, showing that intranasal drug delivery can offer healthcare providers an important alternative administration route, with potential benefits including ease of use and rapid onset of action.

Intranasal Scopolamine Development Program
Defender is working with the United States Naval Medical Research Unit (NAMRU-D) and the National Aeronautics and Space Administration (NASA) on its intranasal scopolamine development programs that are focused on specific military personnel and astronauts.

Defender is also developing intranasal formulations designed to treat a wide variety of indications. We believe these new products have the potential to help safeguard health across civilian and military populations.

About Motion Related Discomfort
Certain motions cause discomfort in individuals while engaged in a variety of leisure or travel related activities. Most forms of travel, whether on land, in the air, or on the water, can trigger motion-related symptoms  (example: flying, boating/fishing, car, bus, and train). Symptoms induced by motion can also have a detrimental impact on the ability of various military personnel and astronauts to perform assigned duties, potentially impacting readiness and negatively impacting resources. Motion related discomfort is a common and transient response to unfamiliar or unnatural motion or contradictory spatial sensory information, resulting in decrements to performance of tasks, pallor, cold sweating, nausea and vomiting. Prolonged exposure to certain motions may induce sopite-related symptoms such as loss of drive and concentration, drowsiness, sleepiness, apathy, depression, and a feeling of impending doom.

Cautionary Note on Forward-Looking Statements
Various statements in this press release, including but not limited to statements regarding the FDA’s review of the scopolamine intranasal gel NDA and Defender’s plans to commercialize DPI-386 should it be approved by the FDA, are forward-looking statements under securities law. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Examples of forward-looking statements include, among others, statements we make regarding our product candidates and the development thereof, such as the Company’s intranasal scopolamine motion development program; the therapeutic potential of our intranasally administered scopolamine HBr product candidate; the Company’s regulatory plans and timelines for intranasally administered scopolamine HBr, including our planned submission of New Drug Applications for indication(s) expected to be pursued in the near term. The process by which investigational therapies, such as intranasal scopolamine, could potentially lead to an approved product is long and subject to highly significant risks. Other risk factors relevant to Defender include our reliance on third-party contract research organizations; the reliance of Defender on contract manufacturers to supply its products for research, development and commercialization and the risk of supply interruption from such contract manufacturers; the timing, plans and reviews by regulatory authorities of marketing applications such as NDAs for intranasally administered scopolamine HBr; alignment with the FDA on the regulatory pathway to approval for intranasally administered scopolamine HBr; market acceptance for approved product; competition; the possible impairment of, inability to obtain, and costs to obtain intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated during development and following commercialization; and general business, financial, and accounting risks and litigation. The forward-looking statements contained in this press release reflect Defender’s current views with respect to future events as of the date of this press release, and Defender does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

For media inquiries, please contact info@defenderpharma.com. For more information about Defender Pharmaceuticals, please visit www.defenderpharma.com.

Source: Defender Pharmaceuticals, Inc.