Psilocybin

The survey found mindshare for drugs in the pipeline is particularly fragmented. Ask a healthcare professional (HCP) to name a psychiatric medicine and chances are they’ll say a brand approved at least 10 years ago. That finding, which comes from a ZoomRx survey, points to the challenge facing new market entrants as they try to wrestle mindshare from incumbents through marketing.ZoomRx spoke to more than 50 HCPs for the survey. The survey revealed a fragmented market, with the 10 drugs most commonly recalled by HCPs accounting for only around half of total mindshare. On one level, the fragmentation is a positive for companies seeking to win market share, with ZoomRx noting that the lack of dominant players creates opportunities for targeted marketing strategies. But the results also highlight the “considerable challenge facing newer entrants in displacing established treatments from HCP consciousness.” ZoomRx issued that warning after observing that drugs approved more than 10 years ago accounted for 76% of HCP mindshare.Prozac topped the mindshare rankings at 7%, followed by a tie between Vraylar and Abilify for second place. Eli Lilly won FDA approval for Prozac in 1987, and the FDA authorized Abilify in 2002. Vraylar is the newest drug in the top three, having received FDA approval in 2015. The survey offers pointers to companies that want to win mindshare and, by extension, market share. Messaging about efficacy benefits and the safety profile tied for first on a list of factors that keep psychiatric drugs top of mind for HCPs. Tolerability profile placed third, followed by mechanism of action.ZoomRx found mechanism of action ranked lower for approved drugs: Once a medicine is on the market, HCPs appear to be more influenced by its clinical performance than its pharmacological innovation. On the flipside, that finding suggests mechanism of action messaging can help win mindshare for investigational drugs. A survey question about pipeline drugs supported that suggestion. The survey found mindshare for drugs in the pipeline is particularly fragmented, with many HCPs not aware of any specific investigational candidates, but identified commonalities between the molecules that have penetrated the consciousness of physicians.For example, Compass Pathways’ COMP360 psilocybin therapy, the fast-acting ketamine derivative RR-HNK and NRx Pharmaceuticals’ combination of an NMDA receptor modulator and 5-HT2a receptor antagonist topped the mindshare ranking for investigational drugs. ZoomRx said the results indicate “significant interest in ... novel approaches to treating psychiatric conditions with substantial unmet needs.” 

-- 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 -- April 07, 2025 -- 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 www.reunionneuro.com/science/#publications. 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 www.ppdreconnectstudy.com. 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. Initial data from RECONNECT are expected in mid-2025. To learn more about the study and eligibility for enrollment, please visit www.ppdreconnectstudy.com. 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. 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 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. The content above comes from the network. if any infringement, please contact us to modify.