Associated tags: NASA, Health, Medication, Veterans' affairs, Patient, Pharmaceutical industry, Motion, Nausea, Vomiting, Motion sickness, FDA, Food, NDA, Scopolamine
Locations: ST. LOUIS, MO, US
Retrieved on:
Tuesday, January 30, 2024
Nausea,
Motion sickness,
CRL,
FDA,
Food,
Motion,
Symantec Endpoint Protection,
Vomiting,
NDA,
Scopolamine,
Pharmaceutical industry 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.
Key Points:
- 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.”
Retrieved on:
Tuesday, October 24, 2023
Astronaut,
Knowledge,
Comment,
Johnson Space Center,
Polaris Dawn,
Health,
Motion sickness,
Inspiration4,
Scientific research on the International Space Station,
Human,
Orion,
SpaceX,
Doctor of Philosophy,
Research,
PVT,
Spaceflight,
National Aeronautics and Space Act,
Contribution,
International Space Station,
NASA,
Motion,
Pharmaceutical industry,
Dietary supplement,
Mars First study evaluates DPI-386 alone and in combination with sensory augmentation to effectively mitigate motion sickness and improve task performance, in comparison to placebo.
Key Points:
- First study evaluates DPI-386 alone and in combination with sensory augmentation to effectively mitigate motion sickness and improve task performance, in comparison to placebo.
- Second study evaluates the feasibility and efficacy of administering DPI-386 in operational field settings, with both astronaut and ground-control subjects, when exposed to provocative motion.
- Both trials are being led by primary investigator Scott J Wood, PhD of NASA, and Neuroscience Laboratory Principal Investigator.
- As the only clinical pharmacologist at NASA, Dr. Putcha was responsible for directing and conducting the research and development program for optimizing pharmacotherapeutics in space.
Retrieved on:
Tuesday, September 26, 2023
Priority review,
Prescription Drug User Fee Act,
ST,
U.S. Navy Diving Manual,
NDA,
Motion,
Patient,
FDA,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
Food,
Pharmaceutical industry,
PDUFA 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).
Key Points:
- PDUFA date of January 26th, 2024
Submission based on five Phase III clinical trials, including overwhelmingly positive results from the -33 Phase 3 study
ST. LOUIS, Sept. 26, 2023 (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 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.
- “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.
Retrieved on:
Thursday, August 10, 2023
US Foods,
Central nervous system,
New Drug Application,
Motion sickness,
Absorption,
Scopolamine,
Vomiting,
Incidence,
Motion,
Nausea,
Transport,
Safety,
Pharmaceutical industry ST. LOUIS, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced that the previously reported, positive results from its Phase 3 clinical trial with DPI-386 Nasal Gel for prevention of nausea and vomiting induced by motion in adults has been selected for presentation at the upcoming 2023 Military Health System Research Symposium (MHSRS) to be held August 14 -17, 2023 in Kissimmee, FL.
Key Points:
- ST. LOUIS, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced that the previously reported, positive results from its Phase 3 clinical trial with DPI-386 Nasal Gel for prevention of nausea and vomiting induced by motion in adults has been selected for presentation at the upcoming 2023 Military Health System Research Symposium (MHSRS) to be held August 14 -17, 2023 in Kissimmee, FL.
- “The selection of our Phase 3 clinical trial results for presentation at this premiere event underscores both the strength of the data and the heavy impact that motion sickness has on the ability to ensure effective military operations,” said Barry I. Feinberg, M.D., President & CEO of Defender Pharmaceuticals.
- Abstract title: Efficacy of Intranasal Scopolamine HBr (INSCOP, DPI-386) for the prevention of vomiting or the need for rescue medication associated with motion.
- The poster will be available on the Company’s website at https://defenderpharma.com/ shortly after the event.
Q fever,
Regulated Activation Networks,
United States Army Medical Materiel Agency,
Tularemia,
Licensure,
United States Army Medical Research and Development Command,
Chikungunya,
Investigational New Drug,
Venezuelan equine encephalitis virus,
United States Department of the Army,
Government,
Rift Valley fever,
Disease,
Pharmaceutical industry,
Defender Medical Research and Development Command (USAMRDC), to develop and commercialize a total of eight products for use against the following tropical diseases: tularemia (rabbit virus); Venezuelan Equine Encephalitis (two formulations); Eastern Equine Encephalitis; Western Equine Encephalitis; Rift Valley Fever; chikungunya and Q Fever.
Key Points:
- Medical Research and Development Command (USAMRDC), to develop and commercialize a total of eight products for use against the following tropical diseases: tularemia (rabbit virus); Venezuelan Equine Encephalitis (two formulations); Eastern Equine Encephalitis; Western Equine Encephalitis; Rift Valley Fever; chikungunya and Q Fever.
- The agreement was entered into on July 25th, 2023 and covers eight investigational vaccines that have been part of the Army’s Special Immunization Program.
- Under the agreement, USAMMDA will transfer the Investigational New Drug applications for each of the eight products, related data, and biological materials to Defender.
- Development work on these products will commence once this transfer is complete.
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
Key Points:
- Reduction in Nausea including Moderate to Severe Nausea with DPI-386 was also demonstrated to be statistically significant relative to placebo (p
- “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.
- 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.
- “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.”
DPI-386 Nasal Gel achieved the primary endpoint in this recently completed, confirmatory Phase III clinical trial, DPI-386-MS-33, a randomized, double-blind, placebo-controlled Phase 3 study of the efficacy and safety of DPI-386 Nasal Gel versus placebo.
Key Points:
- DPI-386 Nasal Gel achieved the primary endpoint in this recently completed, confirmatory Phase III clinical trial, DPI-386-MS-33, a randomized, double-blind, placebo-controlled Phase 3 study of the efficacy and safety of DPI-386 Nasal Gel versus placebo.
- Reduction in Moderate-Severe Nausea with DPI-386 was also demonstrated to be statistically superior to placebo (p
- “The results from this confirmatory pivotal Phase III trial DPI-386-MS-33 demonstrated that DPI-386 effectively prevents nausea and vomiting induced by motion,” said Barry I. Feinberg, M.D., President & CEO of Defender Pharmaceuticals.
- To date, more than 1,300 patients have participated in Defender clinical studies, including over 500 participants in the recently completed DPI-386-MS-33 study.
