Trismus

Dental anxiety and mistrust are among the leading reasons individuals avoid dental treatment. Approximately 36% of people in the U.S. have a fear of dental care, with 12% experiencing extreme fear. This leads to missed appointments, neglected tooth pain, and poor oral health. Fortunately, emerging dental technologies are significantly improving patient care and outcomes, helping to reduce the prevalence of anxiety and mistrust associated with dental treatments. The prevalence and impact of dental anxiety Due to its impact on overall health and quality of life, dental anxiety is categorized as a major public health concern. Each year, 40 million Americans avoid the dentist because of anxiety, resulting in serious consequences for their oral health. Individuals experiencing dental anxiety are more likely to have at least one missing or decaying tooth and are at higher risk of gum disease and early tooth loss. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech The fear of dental treatment affects a patient’s overall quality of life. One in three Americans aged 50-64 feel ashamed about the state of their teeth, and 38% report that dental conditions have caused them pain, difficulties with eating, or interference with their daily lives. With one in six individuals over the age of 65 missing all their teeth, it is apparent that improvements in the dental industry are urgently needed. Establishing trust and understanding patients’ fears is critical for providing relief. Doctors can reduce mistrust by walking patients through the process, discussing their concerns, and presenting potential solutions. This allows patients to visualize and participate in their dental treatment. In addition to thorough communication, advancements in dental technology have revolutionized the patient experience. Tech innovations are revolutionizing the dental industry Innovations such as intraoral digital scanners and advanced radiology tools can significantly minimize dental anxiety. For example, intraoral digital scanners eliminate the discomfort associated with traditional dental mold trays, which are often used to capture replicas of patient’s mouths for implants, braces, and orthodontic procedures. These molds can be uncomfortable, and patients with fragile or loose teeth may worry that the mold could dislodge their teeth. Intraoral digital scanners offer a convenient alternative for patients with vulnerable teeth. The non-invasive scanner is a small, handheld device that is placed in the patient’s mouth and carefully moved across their teeth and gums to create a fully digital and more accurate image of the mouth. Dentists can also utilize extraoral radiology, including cone beam CT scans, to reduce the need for excessive sensors placed in the mouth. These tools enable patients to visualize every step of their treatment, providing security and confidence. presented by Market Trends to Watch for Health Systems and Their Specialty Pharmacies The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients. By Jake Gaffey, MBA, Chief Strategy Officer at Shields Health Solutions Virtual smile design technology elevates visualization by allowing patients to see an image of what their appearance could look like following treatment. The process involves taking images of a patient’s teeth and smile and manipulating the data to design an improved smile. Patients can see an accurate representation of their future results, which incorporates their tooth shape, size, color and alignment. Additionally, the integration of 3D printers significantly improves efficiency for both providers and patents, by enabling dental providers to manufacture essential treatment components in-office. This technology not only streamlines the workflow for providers, but also aids the timeliness of patient solutions.This not only showcases the dental provider’s expertise but also helps patients make informed decisions with clear expectations. These innovations contribute toward creating a safer and more comfortable environment while reducing possible triggers. Triggers can include the prolonged time patients spend with their mouth open, which may cause pain and discomfort for individuals with trismus or limited jaw mobility. Trismus can result from TMJ disorders, trauma, muscle or nerve dysfunction, or oral cancer treatments. Other triggers diminished by technology include lack of knowledge about treatment details and uncertainty around results. Enhancing patient care The integration of the latest technologies improves diagnostic quality and accelerates treatment solutions, decreasing the time patients spend in discomfort or pain due to dental issues. Modern oral scanning technology creates state-of-the-art imagery of the patient’s mouth, providing a detailed view of the condition of the teeth to better inform treatment plans. Improved reliability and consistency in diagnosing patients support dynamic, individualized treatment plans. The adoption of patient-centric technologies enriches dental treatments, making them more personalized and tailored to patient needs. Dental providers can adjust their approaches based on individual concerns, dental history, and oral health demands. Cutting-edge materials used in treatments, such as dental implants, are customized to the exact specifications of a patient’s mouth, optimizing comfort and improving patient outcomes. Workflows are now efficiently streamlined through the integration of these technologies, contributing to expedited results. Today’s patients are looking to avoid healthcare treatments that require multiple visits. In a survey conducted by Futuredontics, 30% of respondents said convenience is the top reason for selecting their dentist. While dental implants typically require 3-10 appointments, innovations in modeling synthesize dental treatments, providing access to oral surgeons, prosthodontists, and dental labs under one roof. This model minimizes appointments and reduces the time patients spend in the chair, allowing them to feel more at ease with treatment decisions and boosting their confidence in overcoming their fears. For dental professionals seeking the latest technology for their patient base, be sure to understand what exactly you need and properly vet the software or hardware before implementation. It’s important to understand how this will add value to your patients and staff. As healthcare providers, we are obligated to strive for the highest quality of care, and with the integration of the right advanced technologies, we can help alleviate dental anxiety and mistrust in the industry. Picture: Nastasic, Getty Images Theresa WangDr. Theresa Wang is the chief clinical & development officer at ClearChoice Dental Implant Centers. She received her doctorate degree at the University of Illinois at Chicago. She then completed advanced training and certification in prosthodontics at the University of North Carolina at Chapel Hill, where she concurrently earned a Masters degree in prosthodontics and completed and published clinical research on dental implants. She has extensive training with the latest dental technologies and dental materials. Dr. Wang also holds an Illinois license as a Dental Specialist in Prosthodontics. By combining her knowledge of the most current dental technologies with her particular aesthetic eye, she is equipped to design smiles that have substantial effects on her patients’ lives.This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.

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.

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. ST. LOUIS, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Defender Pharmaceuticals, Inc. (the “Company” or “Defender”), a privately held life sciences company based in St. Louis, today announced it has initiated two Phase 2 clinical studies, in collaboration with investigators from the United States National Aeronautics and Space Administration (NASA), investigating the ability of DPI-386 (intranasal scopolamine gel) to mitigate G-transition induced motion sickness and enhance sensorimotor performance. “Positive results from either or both of these clinical studies will bolster the growing body of data supporting the use of DPI-386 to prevent the symptoms associated with motion while also potentially expanding the breadth of applications for which intranasal scopolamine gel can serve this purpose,” remarked Dave Helton, Defender’s Chief Scientific Officer. “We are excited and eager to get enrollment in these studies underway as soon as possible, in anticipation of results in second quarter 2024.” The first of these Phase 2 clinical trials is a randomized, double-blind, placebo-controlled, cross-over investigation comparing motion sickness symptom severity and time to severe malaise in 30 subjects, age 18 to 65 years, during exposure to simulated wave motion on a 6DOF platform inside of a crew capsule mockup. This trial will compare four conditions of DPI-386 with sensory augmentation, DPI-386 without sensory augmentation, placebo control with sensory augmentation, and placebo control without sensory augmentation. Subjective side effects and performance on the Psychomotor Vigilance Test (PVT) will also be obtained. The second of these Phase 2 clinical trials is an open-label, non-randomized evaluation of the feasibility and efficacy of self-administered DPI-386 in operational field settings for approximately 80 astronaut and ground-control subjects, age 18 years or older, exposed to provocative motion as part of their assigned duties. Astronaut participants may choose to test DPI-386 during provocative preflight training exercises as well as to prevent or treat symptoms associated with motion during the launch and/or landing mission phases. Examples of provocative motion for ground-control subjects include motion simulations, parabolic flights or Orion capsule recovery operations. All participants will initially be required to test DPI-386 during a training session to monitor for adverse side effects. Participants will complete short debrief questionnaires to capture motion sickness symptoms, side effects, and feasibility comments. Investigators will also require field "control" subjects, not administered DPI-386, to comment on alternative countermeasures used and their effectiveness. Astronaut recruitment will be from among participants in free-flier missions (e.g., SpaceX, Inspiration 4, Polaris Dawn), Private Astronaut Missions (e.g., Axiom), and standard missions to the International Space Station. Both trials are being led by primary investigator Scott J Wood, PhD of NASA, and Neuroscience Laboratory Principal Investigator. Additional information on both clinical trials can be found at clinicaltrials.gov. Acknowledging the Contributions of Dr. Lakshmi Putcha The design and development of the protocols for each of these studies would not have been possible without the contributions of NASA pharmacologist Dr. Lakshmi Putcha. Dr. Putcha passed away in 2015 but left a legacy at NASA that paved the way for innovative research like that described in these two studies that continues to benefit space travelers to this day. Dr. Putcha served as chief pharmacologist at NASA-Johnson Space Center and technical manager of the Pharmacotherapeutics Laboratory at the Johnson Space Center. 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. Her contributions include significantly expanding knowledge of the wide-ranging effects of space flight on humans, as well as resolving critical human health and safety issues for all missions, including ones to Mars. 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 defenderpharma.com. About DPI-386 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 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 recently completed 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. 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 a New Drug Application for intranasal scopolamine and the 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.