Latest news with #FDA-Approved
Medscape
2 days ago
- Health
- Medscape
New Guidance on the Use of Unproven Neurologic Therapeutics
A new position statement outlining guiding principles for navigating the use of unproven therapies for neurologic conditions that lack approval from the FDA or robust scientific evidence has been released by the American Academy of Neurology (AAN). The statement is intended to support informed conversations between clinicians, patients, and policymakers about emerging or unproven treatments. While it includes examples of such therapies, the document stops short of offering clinical recommendations. The use of emerging neurologic therapies not yet supported by science has been 'an ongoing concern,' with patients often asking providers about these therapies, the statement's lead author Larry B. Goldstein, MD, professor and chair of the Department of Neurology and associate dean for Clinical Research, University of Kentucky, Lexington, Kentucky, told Medscape Medical News. Developed in response to requests from AAN members seeking guidance on emerging therapeutics, the statement outlines guiding principles to support clinical and policy discussions. It was published online on June 25 in Neurology. Lack of FDA-Approved Options Many neurologic diseases have no available FDA-approved therapeutic options and no, or limited, evidence-based treatments. However, many potential treatments, both synthetic and naturally occurring, may be in varying stages of expert evaluation for neurologic conditions. Psychedelics have emerged as potential therapies for pain disorders such as cluster headache, as well as psychiatric conditions including major depression, posttraumatic stress disorder (PTSD), generalized anxiety, and substance use disorders. However, data on psychedelics' risks and benefits for these indications are limited. The AAN committee cites the example of midomafetamine combined with psychotherapy for the treatment of PTSD. Although this approach has generated interest, an FDA advisory committee recently recommended against its approval, citing significant methodological flaws in the supporting studies and advising the FDA to reject the Investigational New Drug Application. 'This illustrative example highlights the need for rigorous, placebo-controlled, double-blind trials to adequately test the effectiveness of these therapies while exhaustively documenting adverse events to characterize patient safety issues,' the statement's authors noted. The AAN supports the FDA-accelerated review of novel therapeutics for neurologic conditions 'when this process is appropriate,' said Goldstein. Off-Label Use The statement also addresses the expanded use of therapies beyond their original FDA-approved indications — for example, the off-label use of alteplase for thrombolysis in ischemic stroke patients treated 3-4.5 hours after they were last known to be well, as well as the use of tenecteplase in select cases of acute ischemic stroke. Goldstein noted that these examples reflect issues commonly encountered in hospitals nationwide. 'The AAN supports the off-label use of FDA-approved therapies in settings in which the high-quality evidence indicates that the benefit of the therapy outweighs the risks with shared decision-making between the patient and physician in the model of informed consent,' the statement authors noted. Another example is natalizumab, a humanized IgG4κ monoclonal antibody approved for the treatment of relapsing-remitting multiple sclerosis (MS). The drug was initially withdrawn from the market following reports of progressive multifocal leukoencephalopathy. However, it was later reintroduced, as some patients with MS have no alternative therapies to effectively manage their disease. Physician-patient discussions about unproven therapies might include situations where patients are considering their 'Right to Try.' Signed into law in 2018, the Right to Try Act allows individuals with a terminal illness who have tried all approved treatments and who are unable to participate in a clinical trial to receive an experimental treatment. The statement also addresses the issue of adverse events reported after FDA approval. For example, the statin cerivastatin was approved for cholesterol reduction but was withdrawn from clinical use following reports of deaths and hospitalizations. These cases, said Goldstein, illustrate the complexity of this issue. 'It's particularly challenging because healthcare providers must be constantly aware of new data that may become available as therapeutics enter general use after FDA approval,' said Goldstein. In cases where a therapy is approved but carries significant risks or an incomplete adverse event profile, the statement advises that the AAN should generally refrain from taking a definitive position until further review by the FDA is completed. Unproven 'Treatments' The authors also address the use of therapeutics with limited or no supporting data, many of which have been popularized on social media, to treat or prevent conditions such as dementia. Such use not only exposes patients to unknown risks but may also discourage them from pursuing evidence-based treatments or participating in clinical trials that could offer potential benefits, Goldstein noted. When seeing patients, healthcare providers should discuss potential participation in a relevant trial and ask more detailed questions about the use of unproven therapies, he said. 'Physicians should routinely not only confirm their patient's prescribed medications but also ask about any other substances they may be using. Some, including certain supplements, may have potential toxicities or interactions with prescribed medications.' Discussions between neurologists and patients about unproven therapies are becoming increasingly relevant. 'In the current climate of unfiltered, at times incorrect or misinterpreted information, having a trustworthy source of fact-based advice is critically important,' said Goldstein. 'The neurologist brings particular expertise and training related to neurological disorders and what is known about the risks and benefits of potential treatments to help inform patient decisions,' he added. The AAN policy statement offers 'a framework' to guide neurologists in their role as patient advocates, Goldstein added. Although it does not address specific treatments, it does provide a structure for conversations with patients, said Goldstein.
Time Business News
30-04-2025
- Health
- Time Business News
How Psychiatrists Determine If Spravato Treatment Is Right for You
Choosing the right path to healing isn't always straightforward—especially when it comes to managing treatment-resistant depression (TRD). For individuals who haven't found success with traditional antidepressants, Spravato (esketamine nasal spray) has become a groundbreaking option. But how do psychiatrists determine whether you're a candidate for Spravato? If you're considering Spravato in NYC, understanding the evaluation process can help you feel confident and prepared. In this article, we'll unpack how psychiatrists assess suitability for Spravato treatment, the criteria they use, and the steps involved to ensure you get the safest and most effective care. Before diving into the decision-making process, let's briefly revisit what Spravato is: Esketamine Nasal Spray : A fast-acting medication derived from ketamine, approved for adults with TRD and major depressive disorder (MDD) with suicidal ideation. : A fast-acting medication derived from ketamine, approved for adults with TRD and major depressive disorder (MDD) with suicidal ideation. FDA-Approved : Since 2019, offering new hope to those who haven't responded to other treatments. : Since 2019, offering new hope to those who haven't responded to other treatments. Administered at Certified Centers: Like many facilities offering Spravato in NYC, treatment must occur under medical supervision. Spravato works differently from traditional antidepressants by targeting the glutamate system to enhance brain plasticity and mood regulation. Psychiatrists begin with a full psychiatric evaluation, which includes: Mental Health History : Diagnoses, treatments, hospitalizations. : Diagnoses, treatments, hospitalizations. Medication History : Which antidepressants have been tried, for how long, and at what dosages. : Which antidepressants have been tried, for how long, and at what dosages. Current Symptoms : Depression severity, suicidal thoughts, functional impairments. : Depression severity, suicidal thoughts, functional impairments. Family History: Genetics can play a role in mental health treatment response. Clinics providing Spravato in NYC often use standardized diagnostic tools like the DSM-5 criteria to guide this process. Spravato is reserved for treatment-resistant cases. Psychiatrists must confirm that: You have tried at least two different antidepressants at therapeutic doses. You adhered to treatments for at least 6-8 weeks each time without sufficient improvement. Patients receiving Spravato in NYC are required to provide medical records or pharmacy histories to document previous treatment failures. Spravato is powerful—but not for everyone. Certain conditions can make it unsafe, so psychiatrists screen for: Cardiovascular issues (e.g., hypertension, aneurysms) (e.g., hypertension, aneurysms) Substance abuse (past or present) (past or present) Psychotic disorders (e.g., schizophrenia, schizoaffective disorder) (e.g., schizophrenia, schizoaffective disorder) Pregnancy and breastfeeding status Before beginning Spravato in NYC, a physical exam and lab work (blood pressure, liver function tests, etc.) are often required. Because Spravato has dissociative properties and some abuse potential, psychiatrists carefully assess your substance use history: Alcohol misuse Illicit drug use Prescription medication misuse For patients seeking Spravato in NYC, an open, honest discussion about substance use ensures safe and effective treatment planning. Psychiatrists also gauge: Coping skills Motivation for therapy Ability to participate in a structured treatment program Many centers offering Spravato in NYC integrate talk therapy into treatment because Spravato works best when combined with psychological support. Many insurers covering Spravato in NYC require: Documentation of antidepressant failures Prior authorization paperwork Ongoing progress reports Psychiatrists and clinic staff often help patients navigate these processes to minimize delays. Because you cannot drive after a Spravato session (due to possible sedation and dissociation), psychiatrists will ask about: A designated driver for each treatment day Emotional support at home Access to emergency help if needed Clinics administering Spravato in NYC sometimes require a 'treatment buddy' commitment for safety. Here's how decisions typically break down: ✅ Good Candidate: Diagnosed with TRD or MDD with suicidal ideation Failed multiple antidepressants No disqualifying medical conditions Engaged in therapy or willing to start Reliable support system ❌ Not Yet Ready: Active substance use disorder Uncontrolled physical health issues Untreated psychosis Refusal or inability to comply with post-treatment monitoring In short: eligibility for Spravato in NYC depends on readiness, safety, and clear medical need. Once you're approved, here's what you can expect: Induction Phase : Twice-weekly Spravato treatments for 4 weeks : Twice-weekly Spravato treatments for 4 weeks Maintenance Phase : Weekly or biweekly sessions based on progress : Weekly or biweekly sessions based on progress Observation Period : Mandatory 2-hour monitoring after each session : Mandatory 2-hour monitoring after each session Ongoing Psychiatric Check-Ins: Regular mood evaluations and side-effect monitoring Clinics offering Spravato in NYC create custom schedules to fit your needs while following REMS (Risk Evaluation and Mitigation Strategy) program protocols. Psychiatrists track: Symptom reduction via PHQ-9 or MADRS scores Side effects (e.g., dizziness, nausea, dissociation) Improvements in daily life functioning (e.g., work, relationships, hobbies) If no improvements are seen within 8–12 weeks, psychiatrists may adjust treatment plans or explore alternative options. After two months of integrated Spravato sessions and weekly therapy: Her PHQ-9 scores dropped by 60% - She returned to work full-time - She reported better sleep, higher energy, and restored hope Emma's story mirrors that of many who find renewed life through carefully selected Spravato treatment. Truth: Only those with treatment-resistant depression or acute suicidal ideation qualify. Truth: Esketamine (Spravato) is different from IV ketamine; many patients tolerate it better. Truth: Combining therapy with Spravato leads to stronger, longer-lasting outcomes. The decision to start Spravato isn't taken lightly. Psychiatrists use a thorough, patient-centered approach that evaluates your mental health history, physical health, support system, and readiness for deep healing. If you're exploring Spravato in NYC, trust that your psychiatric team is working to ensure this transformative treatment is safe, appropriate, and maximized for your success. TIME BUSINESS NEWS
Yahoo
07-04-2025
- Health
- Yahoo
Reunion Neuroscience Presents REKINDLE, a Phase 2 Clinical Trial Evaluating RE104 for the Treatment of Adjustment Disorder (AjD) in Cancer and Other Medical Illnesses at the Anxiety & Depression Association of America (ADAA) 2025 Conference
-- AjD is a Mental Health Condition Triggered By a Stressful Life Event; Particularly Common in People with Serious Medical Illness -- -- AjD Represents an Area of Significant Unmet Need; No FDA-Approved Therapies Currently Available -- -- Expansion of Clinical Development Program into AjD in Cancer and Other Medical Illnesses Reflects Broad Potential of RE104 to Revolutionize Mental Health Treatment -- -- Initiation of REKINDLE Phase 2 Trial Expected Mid-2025 -- MORRISTOWN, N.J., April 07, 2025 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions, presented the study design for the REKINDLE Phase 2 clinical trial, which will evaluate the safety and efficacy of RE104 for the treatment of adjustment disorder (AjD) in patients with cancer and other medical illnesses. The study design was presented in a poster session at the Anxiety & Depression Association of America (ADAA) 2025 Conference, held April 3-5, 2025, in Las Vegas, NV. A copy of the poster is available at AjD is a mental health condition defined as a disproportionate reaction to a stressful life event or change, which impacts the ability to function and is characterized by depression, anxiety and/or other behavioral and mood disturbances. Serious medical illnesses are known to be a key precipitant of AjD; it is estimated that approximately 500,000 people in the United States are diagnosed with AjD each year following a medical or health-related stressor. Depressive and anxiety symptoms in medically ill patients with AjD can be associated with poorer medical outcomes, treatment compliance and quality of life as well as increased health care utilization. Current treatments for AjD are not consistently effective, and there are no therapies presently approved by the U.S. Food and Drug Administration (FDA) for its treatment. With RE104, the only psychedelic therapeutic in advanced clinical development for an AjD indication in the United States, Reunion Neuroscience aims to offer patients an effective, safe and fast-acting psychotropic medication to relieve distress and dysfunction in patients with AjD. 'The unveiling of our REKINDLE Phase 2 clinical trial marks an important step in our efforts to expand the clinical development of RE104. Similar to postpartum depression (PPD), where we are currently evaluating RE104 in the RECONNECT Phase 2 clinical trial, AjD is a devastating psychiatric condition that meaningfully impacts quality of life and is often marked by depression and/or anxiety,' said Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience. 'With RE104, we believe we can leverage the power of 4-OH-DIPT to offer a rapid onset, short duration psychedelic experience that delivers immediate, substantial and sustained improvement to patients with AjD. We look forward to initiating REKINDLE in mid-2025 as we pursue our mission of transforming the care and treatment of mental health disorders through the advancement of next-generation psychedelic-inspired solutions.' The REKINDLE Phase 2 clinical trial is a randomized, double-blind, parallel-group, dose-controlled clinical trial evaluating the safety and efficacy of RE104 for the treatment of AjD in adult patients with cancer and other medical illnesses. The primary endpoint of the trial is the change in total Montgomery-Asberg Depression Rating Scale (MADRS) score, a clinician rated scale measuring depression severity from baseline, at Day 14. A key secondary endpoint of the trial is the change in Hamilton Anxiety Scale (HAM-A), a clinician rated scale measuring anxiety severity from baseline, at Day 14. The study will also assess safety and tolerability of RE104. 'AjD represents a significant unmet need -- it is debilitating both in its own right, and in the impact it can have on overall health outcomes in patients suffering from medical illnesses,' said Mark Pollack, M.D., Chief Medical Officer of Reunion Neuroscience. 'The importance of treating mental health in parallel with serious diseases is becoming increasingly well-recognized, and we are eager to introduce RE104 as an innovative solution, which can potentially rescue patients from the impact depression and anxiety may otherwise have on their physical well-being and recovery. As we approach mid-2025, we look forward to announcing initial data for RE104 in PPD, a disease that manifests much like AjD, and to initiating the REKINDLE trial.' Reunion Neuroscience is also evaluating RE104 in RECONNECT (NCT06342310), a multicenter, randomized, double-blind, active dose-controlled Phase 2 clinical trial evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. Initial data from RECONNECT are expected in mid-2025. To learn more about the study and eligibility for enrollment, please visit About RE104The Company's lead product candidate, RE104, is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT. Reunion designed RE104 to deliver a short duration psychedelic experience compared to longer duration psychedelics like psilocybin. In a Phase 1 clinical trial, RE104 produced a psychedelic state similar in intensity and quality to psilocybin, but lasting only about half the time (3-4 hours), while demonstrating a similar, favorable safety profile. RE104 is currently being evaluated in the RECONNECT Phase 2 (NCT06342310) clinical trial, a multicenter, randomized, double-blind, active dose-controlled clinical trial in moderate-to-severe postpartum depression (PPD) patients. Initial data from RECONNECT are expected in mid-2025. To learn more about the study and eligibility for enrollment, please visit Reunion plans to initiate the REKINDLE Phase 2 clinical trial, a randomized, double-blind, parallel-group, dose-controlled trial in AjD in cancer and other medical illnesses in mid-2025. About Reunion Neuroscience Neuroscience is a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic therapeutic solutions. In 2023, Reunion Neuroscience became a private company and in 2024, the Company completed a Series A financing co-led by MPM BioImpact and Novo Holdings. Reunion is actively investigating the use of its lead product candidate, RE104, in postpartum depression and adjustment disorder, as well as in additional neuropsychiatric indications where there remains a significant unmet need that is not addressed by the current standard of care. For more information about the company, visit IR Inquiries:Hannah DeresiewiczPrecision PR Inquiries:Ashley Murphy Precision in to access your portfolio
Associated Press
19-03-2025
- Health
- Associated Press
Gloss Medical Aesthetics & Laser Pioneers Safe & Effective Laser Hair Removal for All Skin Tones with FDA-Approved Technology
Baltimore, USA - Gloss Medical Aesthetics & Laser, a premier provider of advanced beauty and skincare treatments, is proud to reaffirm its commitment to inclusive beauty with FDA-approved laser technology. Specializing in safe and effective laser hair removal for a diverse range of skin tones, including darker skin, Gloss Medical Aesthetics & Laser is dedicated to providing exceptional results for all clients. With the evolution of aesthetic technology, many individuals with darker skin tones have struggled to find safe and effective laser hair removal treatments. Traditional laser devices were often limited in their ability to treat melanin-rich skin without the risk of burns or hyperpigmentation. However, Gloss Medical Aesthetics & Laser is changing the game by investing in cutting-edge FDA-approved technology specifically designed to cater to all skin types. Advanced FDA-Approved Laser Technology for All Skin Tones At Gloss Medical Aesthetics & Laser, patient safety and satisfaction are top priorities. The clinic utilizes state-of-the-art laser hair removal systems that are tailored to deliver optimal results with minimal discomfort. Their technology effectively targets hair follicles without causing damage to the surrounding skin, making it a safe and reliable choice for individuals of all ethnic backgrounds. 'Our goal is to make advanced skincare treatments accessible to everyone, regardless of skin tone,' said a representative of Gloss Medical Aesthetics & Laser. 'We understand the concerns that many individuals with darker skin have when considering laser hair removal, and we are proud to offer a solution that is both safe and effective.' The Benefits of Laser Hair Removal at Gloss Medical Aesthetics & Laser: Safe for All Skin Types – The clinic's FDA-approved lasers are designed to work effectively on all skin tones, including melanin-rich skin. Long-Lasting Results – Laser hair removal significantly reduces hair growth over time, offering a convenient and long-term solution to unwanted hair. Comfortable Experience – The advanced cooling technology incorporated into the laser systems helps to minimize discomfort during treatments. Experienced Professionals – The team at Gloss Medical Aesthetics & Laser consists of highly trained and certified professionals who are experts in treating a variety of skin tones. A Commitment to Inclusive Beauty Gloss Medical Aesthetics & Laser believes that beauty treatments should be accessible to everyone. By prioritizing inclusivity in their services, they continue to break barriers in the aesthetics industry, ensuring that clients from all backgrounds feel welcomed and confident in their treatment choices. Their team provides personalized consultations to assess each client's unique skin type and hair removal needs, ensuring customized treatment plans that deliver optimal results. The clinic's focus on safety, efficacy, and inclusivity has positioned it as a trusted name in Baltimore and beyond. Whether clients are looking to eliminate unwanted hair, achieve smoother skin, or enhance their overall confidence, Gloss Medical Aesthetics & Laser remains the go-to destination for top-tier laser hair removal services. Book a Consultation Today For those interested in learning more about laser hair removal and its benefits, Gloss Medical Aesthetics & Laser offers complimentary consultations to discuss individual treatment goals. The clinic encourages prospective clients to take the first step towards smoother, hair-free skin by scheduling an appointment today. For more information, visit or contact Gloss Medical Aesthetics & Laser at 443-998-9258. About Gloss Medical Aesthetics & Laser: Gloss Medical Aesthetics & Laser is a leading provider of aesthetic treatments in Baltimore, USA. Offering a range of advanced skincare and beauty services, the clinic is committed to delivering safe, effective, and inclusive treatments tailored to the needs of all clients. With a focus on cutting-edge technology and exceptional patient care, Gloss Medical Aesthetics & Laser continues to set the standard in the medical aesthetics industry. Media Contact
Globe and Mail
17-03-2025
- Business
- Globe and Mail
$300 Million in Milestones Plus Tiered Double-Digit Royalties from Accepted Terms to License and Distribute NRX-100 Drug: NRx Pharmaceuticals, Inc. (Nasdaq: NRXP)
$NRXP is Poised to Address Over $3 Billion Suicidal Depression Market in the US Developing NRX-101, an FDA-Designated Investigational Breakthrough Therapy for Suicidal Treatment-Resistant Bipolar Depression and Chronic Pain. Aiming to be the First FDA-Approved Medication to Treat Suicidal Depression Designed to Help Address the Needs of Over 13 Million Americans who Seriously Consider Suicide Each Year (CDC). New Drug Application for Treatment of Suicidal Depression; Planned NDA for Accelerated Approval for Bipolar Depression in People at Risk of Akathisia. Accepted Non-Binding Potential Terms to License and Distribute NRX-100 Drug Providing Over $300 Million in Milestones Plus Tiered Double-Digit Royalties. Application to Uplist to NASDAQ Global Market from NASDAQ Capital Market NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. NRXP is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain NRXP has partnered with Alvogen Pharmaceuticals around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI. NRXP is working on a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRXP was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality. Intravenous ketamine is widely accepted as a standard of care for acute treatment of suicidal depression, in the absence of an FDA-labeled product; the only treatment currently approved by the FDA is electroconvulsive therapy (ECT). According to the CDC, 3.8 million Americans make a plan for suicide each year. This represents a $3-5 billion market at expected pricing. Based on the data in the trials referenced above, the Company's regulatory counsel encouraged the Company to file an NDA for suicidal depression for NRX-100. In a January 2025 report, respected investment analysis firm D. Boral Capital assigned NRXP a $31 Price Target. The full report may be viewed at this link: Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update On March 17th NRXP announced its financial results for the quarter and year ended December 31, 2024, and provided a business update. The announcement included the following key highlights: NRXP initiated filing of a New Drug Application ("NDA") to the FDA for NRX-100 (IV Ketamine) for the treatment of Suicidal Depression; planned filing of an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia. Both have anticipated PDUFA dates prior to December 31, 2025 NRXP has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100, providing over $300 million in milestones plus tiered double-digit royalties based on net sales NRXP retained a leading regulatory law firm to file a citizen's petition with the US Food and Drug Administration ("FDA") to remove benzethonium chloride – a toxic preservative -- from presentations of ketamine intended for intravenous use; planned 2Q25 filing of an Abbreviated New Drug Application ("ANDA") for the use of preservative-free ketamine in all current indications Wholly owned subsidiary HOPE Therapeutics, signed non-binding letters of intent to acquire three precision psychiatry centers and is currently completing financial due diligence and definitive agreements. Currently negotiating the terms for the acquisition of six additional centers The HOPE acquisitions are planned to form the foundation for a national network offering interventional psychiatry services to treat suicidal depression, post-traumatic stress disorder ("PTSD") and related conditions NRXP received and negotiating a term sheet from a publicly-traded strategic investor currently engaged in manufacturing Transcranial Magnetic Stimulation ("TMS") devices to provide capital in support of expansion of further HOPE clinic acquisitions. NRXP has engaged BTIG as financial advisor for clinic acquisition and capital formation; leading global financial services firm specializing in investment banking, institutional trading, research, and related brokerage services for strategic growth opportunities. NRXP regained compliance with the NASDAQ market value of listed securities ("MVLS") requirement. Substantially reduced operating costs compared to prior year Management continues to forecast, although no assurances can be given, profitability on a forward-looking run-rate basis by year end 2025 NRXP filed Module 3 (manufacturing) of its New Drug Application ("NDA") for NRX-100 (preservative-free sterile IV ketamine) in a tamper-resistant, diversion resistant packaging presentation in the fourth quarter of 2024. NRX-100 was previously granted Fast Track Designation by FDA in combination with use of NRX-101. Ketamine efficacy data from four clinical trials are intended to support the filing. Three manufacturing lots are now complete, with filed stability data suitable for shelf life exceeding two years at room temperature. The anticipated PDUFA date for this NDA is prior to December 31, 2025. NRX-100 is poised to address the over $3 billion Suicidal Depression market in the US. NRXP has accepted non-binding potential terms from a commercial pharmaceutical company to license and distribute NRX-100 (preservative-free IV ketamine) that provides for over $300 million in potential milestones plus a tiered double-digit royalty, subject to further due diligence and finalized agreement. In December 2024 NRXP demonstrated long term stability and sterility of a patentable formulation of preservative-free ketamine, despite longstanding commercial practice of adding benzethonium chloride as a preservative to commercially supplied ketamine. This preservative is a known caustic and toxic substance that has previously demonstrated corneal neurotoxicity and conjunctival toxicity in patients, and generalized neurotoxicity in the laboratory at microgram concentrations. The concentration in current ketamine preparations is substantially higher, with an extensive body of scientific literature documenting concern. Additionally, chronic administration of ketamine is known to increase the risk of cystitis ( Ref); the relationship of this adverse event to benzethonium chloride is unknown. Now that a long-term stable and sterile preservative-free formulation is available, the Company is filing a citizens petition to seek removal of benzethonium chloride from the human and veterinary ketamine drug supply. NRXP believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients and is consistent with evolving federal policy on toxic preservatives in the US food and drug supply chain. Therefore, in addition to the NDA designed to add treatment of depression to the current ketamine label, the Company plans to file an Abbreviated New Drug Application ("ANDA") in the second quarter of 2025 for the use of preservative-free ketamine in all currently indicated human and veterinary applications. The Company believes it has met all requirements of the ANDA approval process, has demonstrated manufacturing capacity in excess of one million vials per month, and is prepared to supply the broad ketamine market. As a next-generation product, NRXP has developed a novel, patentable pH neutral formulation of ketamine (designed as HTX-100) based on a proprietary excipient that overcomes ketamine's insolubility, that will be suitable for both intravenous and subcutaneous administration. Initial laboratory lots demonstrate shelf stability and ongoing stability is being assessed. Ketamine in its current commercial presentations cannot be administered subcutaneously because of its high acidic (pH 3.5-4.0) properties, an acidity range that is known to cause pain and skin ulcers. This product is expected to undergo clinical testing in 2025/2026 and be ready for FDA approval in late 2026. Oral forms of ketamine and intranasal racemic ketamine have failed to demonstrate sufficiently stable blood levels to replace intravenous ketamine. However, a ketamine formulation capable of achieving clinical benefit via subcutaneous use – in the manner that diabetes drugs are currently administered – could facilitate far broader clinical use of ketamine to treat life-threatening CNS diseases. NRXP has retained a leading regulatory law firm to file the citizen's petition with the US Food and Drug Administration to remove benzethonium chloride, a known neurotoxic substance, from presentations of ketamine intended for intravenous use. NRXP believes that the preservative-free feature of NRX-100 will be deemed of benefit to patients because of the known toxicity of benzethonium chloride in current generic products. NRX-101 (oral D-cycloserine/lurasidone) Bipolar depression affects approximately seven million people in the US. Current treatment options all carry the risk of suicide and akathisia, a side-effect of serotonin active antidepressants which is closely related to suicide. People with bipolar depression and akathisia or suicidality are at imminent risk of self-harm. These patients need better treatment options urgently. NRXP announced its intention to file an NDA for Accelerated Approval under Breakthrough Designation and Priority Review of NRX-101 for the treatment of bipolar depression in people at risk of akathisia, based on the Phase 2b/3 and STABIL-B data. Three manufacturing lots are now complete with more than 12 months of room temperature shelf-stability. The anticipated PDUFA date for this application is prior to December 31, 2025. NRXP estimates that the market for the initial indication is over $2 billion, while the broad bipolar market could exceed $5 billion. Disclosure listed on the CorporateAds website Media Contact Company Name: NRx Pharmaceuticals, Inc. Contact Person: Matthew Duffy, Chief Business Officer Email: Send Email Phone: 484 254 6134 Address: 1201 Orange Street Suite 600 City: Miami State: Florida Country: United States Website:
