Latest news with #ReunionNeuroscience
Globe and Mail
21 hours ago
- Health
- Globe and Mail
Postpartum Depression Treatment Market Size in the 7MM was estimated to be USD 260 million in 2023, and is expected to increase a significant CAGR by 2034, estimates DelveInsight
DelveInsight's 'Postpartum Depression Treatment Market Insights, Epidemiology, and Market Forecast – 2034' report delivers an in-depth understanding of all Postpartum Depression types, historical and forecasted epidemiology as well as the Postpartum Depression market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan. Discover which therapies are expected to grab the Postpartum Depression Market Share @ Postpartum Depression Market Outlook Key Takeaways from the Postpartum Depression Market Report In May 2025, Nanjing Minova Pharmaceutical Co., Ltd. announced a study is a multicenter, randomized, double-blind, placebo-controlled trial. It includes three groups. Each group will enroll 24 participants. The trial aims todetermine： To evaluate the efficacy of MI078 capsules in treating postpartum depression and to explore the optimal dosing regimen for MI078 capsules. In May 2025, Reunion Neuroscience Inc. announced a study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo. In the seven major Postpartum Depression Therapeutics Market, SNRI's and SSRI's constituted 20% market share of the overall Postpartum Depression Drugs Market, while Atypical antidepressants and Antipsychotics held 19% market share, in 2023. In the 7MM, ZURZUVAE is expected to garner Postpartum Depression Therapeutics market revenue of ~USD 600 million by 2034. Among the seven major market, the United States held the highest Postpartum Depression Drugs Market Share (64%) of the overall Postpartum Depression market. Among EU4 and the UK, the UK accounted for the highest Postpartum Depression Treatment Market Size was ~USD 25 million in 2023 Japan accounted for a Postpartum Depression Market Size of ~USD 20 million in 2023, which is expected to increase at a moderate rate by 2034. The leading Postpartum Depression Companies such as Sage Therapeutics, Biogen, Marinus Pharmaceuticals, Lipocine, Brii Biosciences Limited and others. Promising Postpartum Depression Pipeline Therapies such as SAGE-217, Brexanolone, Aripiprazole, Escitalopram, ZULRESSO®, BRII-296, Ganaxolone, Sertraline and others. Stay ahead in the Postpartum Depression Therapeutics Market with DelveInsight's Strategic Report @ Postpartum Depression Treatment Market Postpartum Depression Epidemiology Total Diagnosed Prevalent Population of Maternal Postpartum Depression Download the report to understand which factors are driving Postpartum Depression Epidemiology trends @ Postpartum Depression Prevalence Postpartum Depression Marketed Therapies ZURZUVAE (zuranolone) : Sage Therapeutics/Biogen Zuranolone (SAGE-217) is an investigational, oral, novel medicine in development for postpartum depression (PPD). It is given once daily, a 2-week therapy neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM) specifically designed to relieve several depression disorders, including PPD, major depressive disorder (MDD), and treatment-resistant depression. The GABA system is the major inhibitory signaling pathway of the brain, and the central nervous system (CNS) significantly regulates CNS function. SAGE-217 has been optimized for selectivity to synaptic and extrasynaptic type a γ-aminobutyric acid (GABAA) receptors and a pharmacokinetic profile for daily oral dosing. ZULRESSO: Sage Therapeutics ZULRESSO is a proprietary IV formulation of brexanolone. Brexanolone is chemically identical to allopregnanolone, a naturally occurring neuroactive steroid that acts as a positive allosteric modulator of gamma-aminobutyric acid (GABA) receptors indicated for treating PPD in adults. Brexanolone is available to patients only through a Risk Evaluation and Mitigation Strategy (REMS) program and must be administered at a certified healthcare facility. In addition, patients must be monitored continuously during the drug infusion due to the risk of serious side effects. Notably, ZULRESSO (brexanolone) is the first drug approved by the US FDA specifically for PPD in adults. Postpartum Depression Emerging Therapies Ganaxolone: Marinus Pharmaceuticals Ganaxolone (CCD-1042) is a lead clinical-stage drug candidate that brings a GABAA receptor modulating mechanism and an extensive safety database with exhibited anti-epileptic (antiseizure), anxiolytic (anti-anxiety) and anti-depressive activity in development by Marinus Pharmaceuticals. It is being developed in three different dosage forms (IV, capsule, and liquid) to maximize therapeutic reach to adult and pediatric patients in acute and chronic care settings with severe PPD. Unlike benzodiazepines, ganaxolone exhibits antiseizure and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors. Ganaxolone has been designed with an added methyl group that prevents back conversion to an active steroid, which unlocks ganaxolone's potential for chronic use. In preclinical studies, ganaxolone exhibited potency and efficacy comparable to allopregnanolone. To learn more about Postpartum Depression Treatment guidelines, visit @ Postpartum Depression Clinical Trials Assessment Postpartum Depression Market Outlook Antidepressants, such as Abilify (aripiprazole), Zoloft (sertraline hydrochloride), Spravato (esketamine), Prozac (fluoxetine capsules), Celexa (citalopram hydrobromide), Luvox CR (Fluvoxamine Maleate), and Paxil CR (paroxetine) form the mainstay in the Postpartum Depression treatment. Although these drugs are approved for treating depression-related disorders such as major depressive disorder (MDD), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), treatment-resistant depression (TRD), etc., they are being used as off-label drugs for the treatment of PPD. The type of medication prescribed by the doctors largely depends on the set of symptoms, severity and the specific type of PPD the patient is suffering from. The primary concern about antidepressants is the uncertainty in the outcomes and their side effects on new born due to breastfeeding. Though antidepressants are not necessarily a permanent cure for PPD, they are an important aspect of managing depression symptoms and restoring quality of life. Postpartum Depression Treatment Landscape Antidepressant medications, cognitive-behavioral therapy (CBT), and interpersonal therapy are effective in treating Postpartum Depression. Other Postpartum Depression treatments which may be useful include psychodynamic therapy, light therapy, exercise, and yoga, but the current research evidence about the efficacy of such treatment regimens is more preliminary. Scope of the Postpartum Depression Market Report Coverage- 7MM Study Period- 2020-2034 Postpartum Depression Companies- Sage Therapeutics, Biogen, Marinus Pharmaceuticals, Lipocine, Brii Biosciences Limited and others. Postpartum Depression Pipeline Therapies- SAGE-217, Brexanolone, Aripiprazole, Escitalopram, ZULRESSO®, BRII-296, Ganaxolone, Sertraline and others. Postpartum Depression Market Dynamics: Postpartum Depression Market Drivers and Barriers Postpartum Depression Market Access and Reimbursement, Unmet Needs and Future Perspectives Table of Content 1. Key Insights 2. Report Introduction 3. Postpartum Depression Market Overview at a Glance 4 Executive Summary of Postpartum Depression 5 Key events 6 Disease Background and Overview 7 Treatment and Management 8 Methodology 9 Epidemiology and Patient Population 10 Patient Journey 11 Marketed Therapies 12 Emerging Therapies 13 Postpartum Depression (PPD): Seven Major Market Analysis 14 KOL Views 15 SWOT Analysis 16 Unmet Needs 17 Market Access and Reimbursement 18 Appendix 19 DelveInsight Capabilities 20 Disclaimer 21 About DelveInsight About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Yahoo
19-05-2025
- Business
- Yahoo
Reunion Neuroscience Announces Last Patient Dosed in RECONNECT Phase 2 Clinical Trial of RE104 for the Treatment of Postpartum Depression (PPD)
-- Enrollment Completed on Schedule; Topline Results Expected Q3 2025 -- -- Company to Present Poster Reviewing RE104 Phase 1 Results at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting on May 28, 2025 -- MORRISTOWN, N.J., May 19, 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, today announced the completion of patient enrollment and the last patient dosed in RECONNECT, a Phase 2 clinical trial evaluating RE104 in adult female patients with moderate-to-severe postpartum depression (PPD). Topline results from the study, which enrolled 84 patients, are anticipated in the third quarter of 2025. 'The completion of patient dosing in RECONNECT is a noteworthy accomplishment and reflects the significant enthusiasm from new mothers and their doctors for options that can offer rapid relief for the persistent depression and anxiety that characterizes PPD. Achieving this milestone on time and as planned per protocol also demonstrates the operational excellence of our team and clinical partners,' said Greg Mayes, President and Chief Executive Officer of Reunion. 'We look forward to reporting initial safety and efficacy data in the third quarter, which will provide key insights into RE104's potential as a fast-acting, short-duration psychedelic therapy for the treatment of PPD and other mental health disorders.' The RECONNECT Phase 2 clinical trial (NCT06342310) is a multicenter (38 clinical research sites in U.S.), randomized, double-blind, parallel-group, active dose-controlled clinical trial evaluating the safety and efficacy of a single subcutaneous dose of RE104. The trial was over-enrolled to include 84 adult female patients with moderate-to-severe PPD. The primary endpoint of the trial is the change from baseline at Day 7 in total Montgomery-Åsberg Depression Rating Scale (MADRS) score, a 10-item clinician-rated scale measuring depression severity. Key secondary endpoints include the change in MADRS at other timepoints, response rates (≥ 50% MADRS reduction), remission rates (MADRS ≤ 10), change in Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression of severity and improvement, as well as overall safety and tolerability. Reunion will also evaluate RE104 for the treatment of adjustment disorder (AjD) in adult patients with cancer and other medical illnesses. The Company recently secured IRB approval and has initiated the site selection and activation process for REKINDLE, a randomized, double-blind, parallel-group, dose-controlled Phase 2 clinical trial evaluating the safety and efficacy of RE104 for AjD, and expects to enroll the first patient in mid-2025. ASCP Annual Meeting Poster Presentation Session: Reunion's Chief Medical Officer, Mark Pollack, M.D., will present a poster reviewing previously disclosed safety, pharmacokinetics (PK) and pharmacodynamics (PD) results from the first-in-human Phase 1 clinical trial of RE104 at the ASCP Annual Meeting, taking place May 27-30, 2025 in Scottsdale, AZ. In this Phase 1 trial, a single dose of RE104 was found to be safe and generally well tolerated, with robust PD effects and a short induced psychoactive state of approximately four hours, supporting the advancement of RE104 into the Phase 2 RECONNECT and REKINDLE trials. Details of the poster presentation session are as follows: Poster Title: RE104: A Novel Serotonergic Psychedelic 4-OH-DiPT Prodrug Date: May 28, 2025 Time: 11:15 a.m. MT (1:15 p.m. ET) 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 psychedelic experience compared to longer experience duration with psychedelics like psilocybin or LSD. In a Phase 1 clinical trial, RE104 produced an acute 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 the third quarter of 2025. Reunion plans to initiate the REKINDLE Phase 2 clinical trial, a randomized, double-blind, parallel-group, dose-controlled trial in adjustment disorder 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-inspired therapeutic solutions. In 2023, Reunion became a private company and in 2024, the Company completed 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. To learn more, visit and follow Reunion on LinkedIn and Bluesky. IR Inquiries:Hannah DeresiewiczPrecision PR Inquiries:Ashley Murphy Precision in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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
04-03-2025
- Health
- Associated Press
Reunion Neuroscience Announces Participation in Premiere Maternal Mental Health Event
Reunion to Participate in the 'New Treatment Options Panel' Discussion at the 2025 Maternal Mental Health FORUM on March 18 at 2:30 p.m. ET Patient Enrollment Ongoing in Reunion's Phase 2, 35 Site RECONNECT Study in Postpartum Depression (PPD) MORRISTOWN, N.J., March 04, 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, today announced its participation in The Policy Center for Maternal Mental Health's 2025 Maternal Mental Health (MMH) FORUM, taking place March 18-19, 2025. 'We are honored to participate in this forum as a featured panel presenter. Our partnership with the Policy Center for Maternal Mental Health reflects our belief in the importance of improving awareness of maternal mental health disorders – which impact up to 1 in 5 expecting and postpartum mothers in the United States – and in ensuring screening, diagnosis and treatment is standardized across the health delivery system,' said Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience. 'The MMH FORUM provides a much-needed venue for policymakers, payors and provider leaders to discuss solutions for closing the gaps in maternal mental health care, and we look forward to presenting on RE104 and our ongoing RECONNECT Phase 2 trial, as we work to deliver a potentially new approach to treating postpartum depression, which may offer mothers safe, fast-acting and effective relief.' The RECONNECT Phase 2 clinical trial (NCT06342310), a multicenter, randomized, double-blind, active dose-controlled clinical trial is evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. To learn more about the study and eligibility for enrollment, please visit 'Novel treatment solutions like RE-104, the psychedelic treatment being developed and studied by Reunion Neuroscience, are critical to closing gaps in mental health care and offering patients a range of effective treatments,' said Joy Burkhard, Chief Executive Officer of The Policy Center for Maternal Mental Health. 'Both The Policy Center for Maternal Mental Health and Reunion Neuroscience are committed to advancing policies that expand access to care, ensuring every mother receives timely and effective mental health support.' Presentation at the 2025 Maternal Mental Health (MMH) FORUM Reunion's President and Chief Executive Officer, Greg Mayes, will present on RE104 and the RECONNECT Phase 2 clinical trial as part of a panel discussion, 'New Treatment Options,' at the 2025 Maternal Mental Health FORUM taking place virtually March 18-19, 2025. Details of the panel presentation are as follows: Time: 2:30 p.m. ET About RE104 The 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. Reunion plans to initiate the REKINDLE Phase 2 clinical trial, a randomized, double-blind, parallel-group, dose-controlled trial in adjustment disorder (AjD) in cancer and other medical illnesses. About RECONNECT The RECONNECT Phase 2 clinical trial ( NCT06342310), a multicenter, randomized, double-blind, active dose-controlled clinical trial, is evaluating the safety and efficacy of a single subcutaneous dose of RE104 in adult female patients with moderate-to-severe PPD. To learn more about the study and eligibility for enrollment, please visit About Reunion Neuroscience Inc. Reunion 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 August of 2023, Reunion Neuroscience became a private company and in May 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 The Policy Center for Maternal Mental Health is a non-profit think tank providing data and insights as well as cross-sector policy and practice solutions to prevent the suffering of mothers, babies, and families associated with untreated maternal mental health disorders, like postpartum depression. For more information, visit and follow @PolicyCenterMMH on LinkedIn and X. Hannah Deresiewicz Precision AQ PR Inquiries: Ashley Murphy Precision AQ
