{"id":86805,"date":"2026-04-29T18:02:11","date_gmt":"2026-04-29T18:02:11","guid":{"rendered":"https:\/\/diyhaven858.wasmer.app\/index.php\/fda-approves-caplyta-for-relapse-prevention-in-schizophrenia\/"},"modified":"2026-04-29T18:02:11","modified_gmt":"2026-04-29T18:02:11","slug":"fda-approves-caplyta-for-relapse-prevention-in-schizophrenia","status":"publish","type":"post","link":"https:\/\/diyhaven858.wasmer.app\/index.php\/fda-approves-caplyta-for-relapse-prevention-in-schizophrenia\/","title":{"rendered":"FDA approves Caplyta for relapse prevention in schizophrenia"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div xmlns:default=\"http:\/\/www.w3.org\/1999\/xhtml\" data-component=\"ArticleContent\">\n<div class=\"article__below-title\">\n<div class=\" article__posted-date\">\n<p>April 29, 2026<\/p>\n<p>2 min read<\/p>\n<\/p><\/div>\n<div class=\"mobile-trust-box\">\n<div class=\"row\">\n<div class=\"col-12 col-md-6 offset-md-1 offset-xl-0 col-xl-12\">\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u3aad136a8393451db9a406fde8008307\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<h2>Key takeaways:<\/h2>\n<ul>\n<li>Risk for relapse fell by 63% with Caplyta compared with placebo.<\/li>\n<li>There were no relapses over 6 months for 84% of patients.<\/li>\n<li>No new safety signals emerged, compared with previous data.<\/li>\n<\/ul>\n<p>The FDA has approved Johnson &amp; Johnson\u2019s supplemental new drug application for Caplyta among patients with schizophrenia at risk for relapse, according to a press release from the company. <\/p>\n<p>Noting that schizophrenia affects approximately 2.8 million adults in the United States, with a total cost of $366.8 billion in 2024, Johnson &amp; Johnson said approximately 40% of patients do not receive adequate care.<\/p>\n<figure class=\"figure article__og-image\">&#13;\n    <picture>&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\" media=\"(max-width: 768px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=800\" media=\"(max-width: 992px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=595\" media=\"(max-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\" media=\"(min-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\">&#13;<br \/>\n&#13;<br \/>\n      <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.jpg?w=800\" alt=\"Generic FDA News infographic\" class=\"figure-img img-fluid\" width=\"800\"\/>&#13;<br \/>\n    <\/source><\/source><\/source><\/source><\/source><\/picture>&#13;<figcaption class=\"figure-caption\">&#13;<br \/>\n      The approval targets relapses in schizophrenia, which can lead to worse symptoms, cognition, quality of life and life expectancy.<br \/>&#13;<br \/>\n    <\/figcaption>&#13;<br \/>\n  <\/figure>\n<p>Relapse remains \u201cone of the most critical challenges\u201d for patients with schizophrenia, <b>Leighann Forbes,<\/b> <b>MS, PhD,<\/b> vice president, U.S. neuroscience medical affairs, Johnson &amp; Johnson, told Healio.  <\/p>\n<div class=\"mug left\"><img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/neurology\/mugs\/f\/forbes_leighann_80x106.jpg?h=106&amp;w=80\" style=\"width: 80px; height: 106px;\"\/><\/p>\n<p><strong><b>Leighann Forbes<\/b><\/strong><\/p>\n<\/div>\n<p>\u201cRelapses can disrupt stability, undermine functioning, and often trigger disruptive episodes such as psychosis or hallucinations that can derail daily life for patients and their loved ones,\u201d she said. <\/p>\n<p>Adults with schizophrenia experience an average of nine relapse episodes per 6-year period, according to the release. <\/p>\n<p>\u201cEach relapse can contribute to deterioration in symptoms, cognition, functioning, quality of life and life expectancy,\u201d Forbes said. \u201cThat\u2019s why managing relapse risk is a critical goal in long-term disease management.\u201d<\/p>\n<p>However, physicians often focus on symptoms to reduce risks for relapse instead of treating the relapse itself, Forbes said. <\/p>\n<p>\u201cA comprehensive treatment plan, which could include medication and psychosocial services, can help reduce the risk of relapse for adults with schizophrenia,\u201d she said. \u201cAddressing this risk can help patients maintain functioning, reduce caregiver and societal strain and break the cycle of repeated hospitalizations.\u201d<\/p>\n<p>In a phase 3, double-blind, randomized withdrawal trial, Johnson &amp; Johnson said that daily oral 42 mg doses of Caplyta (lumateperone) significantly extended time to relapse compared with placebo over 26 weeks, with risks for relapse falling by 63%. <\/p>\n<p>Also, 84% of patients on Caplyta did not experience a relapse for 6 months, with significant delays in time to treatment discontinuation due to relapse and all other causes. <\/p>\n<p>Johnson &amp; Johnson further said no new safety concerns were identified during this trial and that its safety profile was consistent with previous data. Headache was the most common adverse event related to treatment. <\/p>\n<p>\u201cTogether, these data reinforce Caplyta as a safe and effective treatment option for adults living with schizophrenia,\u201d Forbes told Healio. \u201cCaplyta can be taken at any time of day and does not require titration, meaning patients can start treatment at the effective dose for them.\u201d<\/p>\n<p>Caplyta was previously approved for adults with major depressive disorder, schizophrenia and depressive episodes associated with bipolar I or II disorder in conjunction with antidepressants, lithium or valproate or as a monotherapy. <\/p>\n<p>\u201cCaplyta can be prescribed to patients who have experienced relapse,\u201d Forbes said. <\/p>\n<p>      <b>For more information:<\/b>    <\/p>\n<p>      <b>Leighann Forbes,<\/b> <b>MS, PhD<\/b><b>, <\/b>can be reached at neurology@healio.com.<\/p>\n<div class=\"article__content--footer\">\n<div class=\"sources-references-disclosures\">\n<h3>Sources\/Disclosures<\/h3>\n<h2> Source: <\/h2>\n<p class=\"citation\">&#13;<br \/>\n  Press Release  <\/p>\n<div class=\"disclosures\">\n<p>&#13;<br \/>\n        <strong> Disclosures: <\/strong>&#13;<br \/>\n        Forbes reports employment with Johnson &amp; Johnson. <\/p>\n<\/p><\/div>\n<\/div>\n<p><!-- Healio AI Widget --><\/p>\n<div class=\"healio-ai-component-inline\" data-no-ads=\"true\" data-module-track-category=\"Healio AI\" data-module-track-action=\"Click\" data-module-track-label=\"Access Healio Ai from component - News_AI Component - In-Content (all devices)\">\n<div class=\"healio-ai-content\">\n    <img decoding=\"async\" src=\"https:\/\/m3.healio.com\/~\/media\/images\/healio-ai\/healio-ai_logo.svg\" alt=\"Healio AI\" class=\"healio-ai-logo\"\/><\/p>\n<p><strong>Ask a clinical question<\/strong> and tap into <strong>Healio AI&#8217;s knowledge<\/strong> base.<\/p>\n<ul>&#13;<\/p>\n<li>PubMed, enrolling\/recruiting trials, guidelines<\/li>\n<p>&#13;<\/p>\n<li>Clinical Guidance, Healio CME, FDA news<\/li>\n<p>&#13;<\/p>\n<li>Healio&#8217;s exclusive daily news coverage of clinical data<\/li>\n<p>&#13;\n    <\/ul>\n<p>    <button class=\"healio-ai-button\" onclick=\"window.location.href=\" https:=\"\">Learn more<\/button>\n  <\/div>\n<\/div>\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u3aad136a8393451db9a406fde8008307\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. 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