July 27, 2023
ST. LOUIS, MO—(BUSINESS WIRE)—Jul. 27, 23—Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced that the Company has submitted its first New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with intranasally administered scopolamine gel (DPI-386 Nasal Gel) for prevention of nausea and vomiting induced by motion in adults.
The NDA submission is 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 primary endpoint in this study was assessment of the effectiveness of DPI-386 (defined as “Complete Response”) in reducing the proportion of participants who reported no vomiting and who did not request rescue treatment in comparison with placebo. Positive results demonstrated that the proportion of participants in the DPI-386 treatment arm who did not report vomiting and did not request rescue treatment was significantly greater (p<0.0001) than participants receiving placebo. Reduction in Nausea including Moderate to Severe Nausea with DPI-386 was also demonstrated to be statistically significant relative to placebo (p<0.0001) during the entire trial period.
“The submission of our first NDA is a key milestone for Defender and positions the Company well for a product launch in a market with substantial need of more effective treatment options,” said Barry I. Feinberg, M.D., President & CEO of Defender Pharmaceuticals. “The submission of our NDA, with such a robust body of supportive efficacy and safety data, brings us one critical step closer to that goal. We look forward to working closely with the FDA during its review process.”
The FDA’s decision on acceptance of Defender’s NDA filing is anticipated in September 2023. Assuming the filing is accepted, the prospective PDUFA date would be in Q1 2024 (under an anticipated priority review process given the U.S. Navy’s formal request for such a review and the FDA’s acceptance of that request). As Defender finalizes its commercialization plans for DPI-386 in the U.S., in anticipation of prospective NDA approval, the Company continues to advance critical pre-launch activities, required under any commercialization scenario, to ensure a robust and targeted commercial launch very soon after its PDUFA action date. In addition, Defender is conducting a private placement offering to raise working capital in support of multiple product development initiatives and intranasal scopolamine commercialization efforts.
“Scopolamine has been available for decades in a transdermal patch formulation and Defender believes its unique intranasal gel formulation, if approved, has the ability to bring fast, effective relief to any adults, including our war fighters, who are seeking to prevent the nausea and vomiting induced by motion,” said David Helton, Chief Scientific Officer of Defender. “Defender would also like thank the clinical investigators and the study participants whose contributions were instrumental to the successful completion of our overall development program.”
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 symptoms such as nausea and vomiting (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 Defender’s plans to continue the intranasally administered scopolamine HBr development program and pursue FDA approval, 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.
1Cha YH, Golding JF, Keshavarz B, et al. Motion sickness diagnostic criteria: Consensus Document of the Classification Committee of the Bárány Society. J Vestib Res. 2021;31(5):327-344. doi:10.3233/VES-200005.
