Scopolamine Hydrobromide Hydrate

Nasa is helping with Defender’s development of DPI-386, as astronauts are particularly susceptible to motion sickness in space. Image credit: Shutterstock/Supamotionstock.com. The FDA has decided to not approve Defender Pharmaceuticals’ intranasal scopolamine candidate for motion sickness, issuing a complete response letter (CRL) to the US-based company. Defender’s drug, known as DPI-386, is indicated for the prevention of nausea and vomiting induced by motion in adults. Defender’s CEO Barry I Feinberg said the company plans on scheduling a formal meeting with the FDA to discuss the issues raised and to create a plan going forward, in a 30 January press release. DPI-386 is a nasal gel version of the antimuscarinic drug scopolamine, first approved by the FDA as a transdermal patch in 1979, according to the drug’s label . Currently, patches are placed behind the ear and work with high efficacy by depressing the parasympathetic nervous system. The gel could be particularly useful for astronauts and military personnel who are frequently exposed to motion. Nasa joined forces with Epiomed Therapeutics to develop a fast-acting nasal spray version of scopolamine in 2012. According to the St Louis Post-Dispatch , Defender purchased Epiomed in 2014 and was founded the same year. Headquartered in St Louis, Missouri, the company has also worked with the United States Naval Medical Research Unit. See Also: Tyra Biosciences’ TYRA-300 gains FDA rare paediatric disease status Revolo advances plans to tackle eosinophilic esophagitis with orphan drug tag Defender’s formulation aims for rapid absorption to induce quicker onset. In a Phase III trial more than 500 participants, who usually get motion sick, had improved symptoms after being exposed to open sea conditions while using DPI-386. Subjects who received the nasal gel demonstrated lower incidences of vomiting and fewer requests for rescue medication compared to a placebo group. The incidence of moderate to severe nausea was also lower. In a September 2023 statement announcing the new drug application (NDA) acceptance, Defender said results from five phase III trials were submitted as evidence. The NDA was assigned priority review status by the FDA at the request of the US Navy. Feinberg added: “We remain confident that our intranasal scopolamine is a safe and effective therapy for the prevention of motion sickness, and we will work closely with the FDA to ensure that we can bring this innovative new product to the market.” Defender is also exploring the use of DPI-386 in major depressive disorder (MDD) with suicide ideation, chemical exposure accidents, and virtual reality sickness. In October 2023, Defender announced further collaborations with Nasa to study DPI-386 in Phase II trials to mitigate G-transition-induced motion sickness and enhance sensorimotor performance. Scopolamine recently made the news beyond the healthcare sector after rising incidences of it being linked to criminal activity. In June 2023, the US Embassy in Colombia highlighted the sedative side effects of the drug are being increasingly used to target tourists in the country.  In certain doses, the drug can cause unconsciousness for 24 hours or more. Scopolamine was also the first drug to infamously garner the “truth serum” tag.

ST. LOUIS, Jan. 30, 2024 (GLOBE NEWSWIRE) -- 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 issued a Complete Response Letter (CRL) in response to the Company’s New Drug Application (NDA) for intranasal scopolamine (DPI-386) for the prevention of nausea and vomiting induced by motion in adults. “Following our review of the CRL, we plan on scheduling a formal meeting with the FDA to fully understand the issues raised in the CRL so we can develop and implement a comprehensive action plan,” said Barry I. Feinberg, M.D., President & CEO of Defender Pharmaceuticals. “We remain confident that our intranasal scopolamine is a safe and effective therapy for the prevention of motion sickness, and we will work closely with the FDA to ensure that we can bring this innovative new product to the market.” About intranasal scopolamine (DPI-386) Development ProgramDefender has worked with the United States Naval Medical Research Unit (NAMRU-D) and the National Aeronautics and Space Administration (NASA) on its intranasal scopolamine development program that is focused on specific military personnel and astronauts. To date, more than 1,300 patients have participated in Defender clinical studies, including over 500 participants in the DPI-386-MS-33 study. Given the successful outcome of DPI-386-MS-33, Defender has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for DPI-386 Nasal Gel for the prevention of nausea and vomiting induced by motion in adults. 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 DiscomfortCertain 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. 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. Additional information can be found at www.defenderpharma.com. 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 sickness 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. 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.