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Cobenfy: A Critical Breakthrough in Schizophrenia Treatment in Over 30 Years

<!doctype html><html lang="en"><head> <meta charset="utf-8"> <title>Cobenfy: A Critical Breakthrough in Schizophrenia Treatment in Over 30 Years</title> <link rel="shortcut icon" href="https://oxfordglobal.com/hubfs/OXFORD_GLOBAL-LOGO_SYMBOL.jpg"> <meta name="description" content="According to a recent press release, the US FDA has approved Cobenfy, a first-in-class muscarinic agonist developed by Bristol Myers Squibb for the treatment of schizophrenia in adults."> <meta name="viewport" content="width=device-width, initial-scale=1"> <meta property="og:description" content="According to a recent press release, the US FDA has approved Cobenfy, a first-in-class muscarinic agonist developed by Bristol Myers Squibb for the treatment of schizophrenia in adults."> <meta property="og:title" content="Cobenfy: A Critical Breakthrough in Schizophrenia Treatment in Over 30 Years"> <meta name="twitter:description" content="According to a recent press release, the US FDA has approved Cobenfy, a first-in-class muscarinic agonist developed by Bristol Myers Squibb for the treatment of schizophrenia in adults."> <meta name="twitter:title" content="Cobenfy: A Critical Breakthrough in Schizophrenia Treatment in Over 30 Years"> <style> a.cta_button{-moz-box-sizing:content-box !important;-webkit-box-sizing:content-box !important;box-sizing:content-box !important;vertical-align:middle}.hs-breadcrumb-menu{list-style-type:none;margin:0px 0px 0px 0px;padding:0px 0px 0px 0px}.hs-breadcrumb-menu-item{float:left;padding:10px 0px 10px 10px}.hs-breadcrumb-menu-divider:before{content:'›';padding-left:10px}.hs-featured-image-link{border:0}.hs-featured-image{float:right;margin:0 0 20px 20px;max-width:50%}@media (max-width: 568px){.hs-featured-image{float:none;margin:0;width:100%;max-width:100%}}.hs-screen-reader-text{clip:rect(1px, 1px, 1px, 1px);height:1px;overflow:hidden;position:absolute !important;width:1px} </style> <link rel="stylesheet" href="https://oxfordglobal.com/hs-fs/hub/8696823/hub_generated/template_assets/135726131582/1732113079147/git/og-stage/css/main.min.css"> <link rel="stylesheet" href="https://cdn.oxfordglobal.com/fontawesome/6.5.1/css/fontawesome.min.css"> <link rel="stylesheet" href="https://cdn.oxfordglobal.com/fontawesome/6.5.1/css/brands.min.css"> <link rel="stylesheet" href="https://cdn.oxfordglobal.com/fontawesome/6.5.1/css/solid.min.css"> <!-- Editor Styles --> <style id="hs_editor_style" type="text/css"> #hs_cos_wrapper_module_17019620504109 { display: block !important; margin-bottom: 0px !important } </style> <!-- Added by GoogleAnalytics4 integration --> <script> var _hsp = window._hsp = window._hsp || []; window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} var useGoogleConsentModeV2 = true; var waitForUpdateMillis = 1000; if (!window._hsGoogleConsentRunOnce) { window._hsGoogleConsentRunOnce = true; gtag('consent', 'default', { 'ad_storage': 'denied', 'analytics_storage': 'denied', 'ad_user_data': 'denied', 'ad_personalization': 'denied', 'wait_for_update': waitForUpdateMillis }); if (useGoogleConsentModeV2) { _hsp.push(['useGoogleConsentModeV2']) } else { _hsp.push(['addPrivacyConsentListener', function(consent){ var hasAnalyticsConsent = consent && (consent.allowed || (consent.categories && consent.categories.analytics)); var hasAdsConsent = consent && (consent.allowed || (consent.categories && consent.categories.advertisement)); gtag('consent', 'update', { 'ad_storage': hasAdsConsent ? 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The condition presents a range of symptoms, including psychosis, social withdrawal, lack of motivation, poor memory, and difficulty focusing. Despite existing treatments, many patients experience limited relief or intolerable side effects, <a href="https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-COBENFY-xanomeline-and-trospium-chloride-a-First-In-Class-Muscarinic-Agonist-for-the-Treatment-of-Schizophrenia-in-Adults/default.aspx" rel="noopener" target="_blank">with up to 60% of people not achieving adequate symptom control</a>.</p> <p style="text-align: justify;">Schizophrenia is also characterised by unpredictable progression and variability in patient response to current therapies. It is estimated that 1.6 million patients in the USA are receiving treatment for schizophrenia. Yet, three<a href="https://www.cnbc.com/2024/09/26/fda-approves-bristol-myers-squibbs-schizophrenia-drug.html" rel="noopener" target="_blank"> quarters of these patients discontinue their medication within the first 18 months due to issues with efficacy or tolerance</a>. This demonstrates the urgent need for new treatment options to better address the diverse needs of those living with the condition.</p> <p style="text-align: justify;"><strong>Cobenfy</strong></p> <p style="text-align: justify;">In a significant milestone, the US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s new drug, Cobenfy, marking the first novel treatment for schizophrenia in over three decades. Cobenfy, a first-in-class muscarinic agonist (a parasympathomimetic drug), represents an innovative approach to treating schizophrenia. &nbsp;</p> <p style="text-align: justify;">Chris Boerner, CEO of Bristol Myers Squibb, further emphasised the significance of this approval: “After more than 30 years, there is now an entirely new pharmacological approach for schizophrenia—one that has the potential to change the treatment paradigm.”</p> <p style="text-align: justify;">Current schizophrenia treatments primarily target dopamine receptors, focusing on managing psychosis and hallucinations but often leading to significant side effects such as motor control issues. Whereas Cobenfy, adopts a novel approach by selectively targeting M1 and M4 receptors, these receptors <a href="https://www.frontiersin.org/journals/cellular-neuroscience/articles/10.3389/fncel.2023.1124333/full" rel="noopener" target="_blank">reduce the severity of positive and negative cognitive symptoms associated with schizophrenia</a> without affecting the dopamine system.&nbsp;</p> <p style="text-align: justify;"><strong>Related: </strong></p> <ul> <li style="text-align: justify;"><a href="https://oxfordglobal.com/discovery-development/resources/beyond-traditional-therapeutics-how-digital-therapeutics-reshape-neurological-and-neuropsychiatric-treatments" rel="noopener" target="_blank">Beyond Traditional Therapeutics: How Digital Therapeutics Reshape Neurological and Neuropsychiatric Treatments</a></li> <li style="text-align: justify;"><a href="https://oxfordglobal.com/discovery-development/resources/alzheimers-brain-awareness-month-spotlight-how-amphista-therapeutics-is-tackling-neurological-disorders" rel="noopener" target="_blank">Alzheimer's &amp; Brain Awareness Month Spotlight: How Amphista Therapeutics is Tackling Neurological Disorders</a></li> <li style="text-align: justify;"><a href="https://oxfordglobal.com/discovery-development/resources/spheroids-assembloids-could-unlock-high-throughput-screening-of-neuro-drugs" rel="noopener" target="_blank">Spheroids, Assembloids Could Unlock High Throughput Screening of Neuro Drugs</a></li> </ul> <p style="text-align: justify;">The FDA’s decision to approve Cobenfy was based on robust data from the EMERGENT clinical program, which consisted of three placebo-controlled efficacy and safety trials that demonstrated the long-term safety and tolerability of Cobenfy for up to one year. However, several patients experienced side effects such as nausea, vomiting, and hypertension.</p> <p style="text-align: justify;"><strong>Future Directions</strong></p> <p style="text-align: justify;">As the first drug of its kind to be approved, Cobenfy sets Bristol Myers Squibb ahead of competitors such as AbbVie and Neurocrine Biosciences, who are in the mid-stages of developing treatments targeting the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006961/" rel="noopener" target="_blank">muscarinic pathway</a>. With analysts predicting that <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-bristol-myers-schizophrenia-drug-2024-09-26/" rel="noopener" target="_blank">Cobenfy will generate $2.5 billion in sales by 2030</a>, it is positioned to become a major player in the schizophrenia treatment market.</p> <p style="text-align: justify;">Bristol Myers Squibb plans to explore Cobenfy’s potential in treating other neuropsychiatric symptoms including bipolar mania. Additionally, ongoing studies aim to evaluate Cobenfy’s efficacy as an add-on therapy for schizophrenia patients who do not respond adequately to existing antipsychotics. Furthermore, there are plans to investigate Cobenfy’s use in treating psychosis associated with Alzheimer’s disease, with trial results expected in 2026.</p> <p style="text-align: justify;"><strong>Conclusion</strong></p> <p style="text-align: justify;">In summary, Cobenfy’s approval signals a shift in the treatment landscape for schizophrenia, offering hope to patients who have struggled to find effective therapies that suit their needs. This breakthrough may also inspire <a href="https://oxfordglobal.com/discovery-development/events/discovery-us-2024" rel="noopener" target="_blank">further innovation in the neuropsychiatric space</a>, encouraging other pharmaceutical companies to focus on the development of novel treatments for complex mental health disorders.</p> <div class="content-body-footer"> </div> </div> <div class="content-sidebar"> <div class="related-articles"> <h3 class="center">Related Resources</h3> <div class="article"> <a href="/discovery-development/resources/beyond-traditional-therapeutics-how-digital-therapeutics-reshape-neurological-and-neuropsychiatric-treatments"> <div class="cover-graphic"> <img src="https://oxfordglobal.com/hubfs/Copy%20of%20Featured%20Image%20(6).png" class="cover-graphic-image"> </div> </a><div class="content"><a href="/discovery-development/resources/beyond-traditional-therapeutics-how-digital-therapeutics-reshape-neurological-and-neuropsychiatric-treatments"> <h4> Beyond Traditional Therapeutics: How Digital Therapeutics Reshape Neurological and Neuropsychiatric Treatments </h4> <div class="abstract"> Two case studies show how digital therapeutics can potentially treat neurological and neuropsychiatric conditions, areas where conventional therapeutics have encountered obstacles. </div> <div class="read-more"> <a href="/discovery-development/resources/beyond-traditional-therapeutics-how-digital-therapeutics-reshape-neurological-and-neuropsychiatric-treatments" class="read-more-link">Read More</a> </div></a> </div> </div> <div class="article"> <a href="/discovery-development/resources/university-of-pennsylvania-and-fast-to-develop-aav-gene-therapy-for-angelman-syndrome"> <div class="cover-graphic"> <img src="https://oxfordglobal.com/hubfs/University%20of%20Pennsylvania%20and%20FAST%20to%20Develop%20AAV%20Gene%20Therapy%20for%20Angelman%20Syndrome.jpg" class="cover-graphic-image"> </div> </a><div class="content"><a href="/discovery-development/resources/university-of-pennsylvania-and-fast-to-develop-aav-gene-therapy-for-angelman-syndrome"> <h4> University of Pennsylvania and FAST to Develop AAV Gene Therapy for Angelman Syndrome </h4> <div class="abstract"> The collaboration hopes to develop a AAV gene therapy for rare genetic disease Angelman syndrome. </div> <div class="read-more"> <a href="/discovery-development/resources/university-of-pennsylvania-and-fast-to-develop-aav-gene-therapy-for-angelman-syndrome" class="read-more-link">Read More</a> </div></a> </div> </div> </div> </div> </div> </div> </div> </div> <div class="newsletter-cta"> <h2 class="heading">Subscribe to our newsletter</h2> <div class="message"> Sign up for our monthly Newsletter to keep up with all things Discovery &amp; 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