{"id":220325,"date":"2025-08-18T07:04:31","date_gmt":"2025-08-18T12:04:31","guid":{"rendered":"https:\/\/lifeboat.com\/blog\/2025\/08\/fda-approves-tonmya-first-fibromyalgia-medication-in-15-years"},"modified":"2025-08-18T07:04:31","modified_gmt":"2025-08-18T12:04:31","slug":"fda-approves-tonmya-first-fibromyalgia-medication-in-15-years","status":"publish","type":"post","link":"https:\/\/lifeboat.com\/blog\/2025\/08\/fda-approves-tonmya-first-fibromyalgia-medication-in-15-years","title":{"rendered":"FDA Approves Tonmya, First Fibromyalgia Medication in 15 Years"},"content":{"rendered":"<p><a class=\"aligncenter blog-photo\" href=\"https:\/\/lifeboat.com\/blog.images\/fda-approves-tonmya-first-fibromyalgia-medication-in-15-years.jpg\"><\/a><\/p>\n<p>The US Food and Drug Administration (FDA) has approved Tonix Pharmaceuticals\u2019 Tonmya (cyclobenzaprine HCl, formerly known as TNX-102 SL), a novel treatment form for fibromyalgia.1 The drug is now the first in a new category of non-opioid analgesics for fibromyalgia and the first new medication for this disorder in 15 years.<\/p>\n<p>The FDA\u2019s approval cited efficacy from 2 double-blind, randomized, placebo-controlled, phase 3 clinical trials of almost 1,000 patients that evaluated Tonmya as treatment for fibromyalgia. Across both phase 3 trials, Tonmya significantly reduced daily pain scores compared with placebo at the primary endpoint of 14 weeks. In these trials, a greater percentage of patients taking Tonmya experienced a clinically meaningful (\u226530%) improvement in their pain after 3 months, as compared with placebo. Across phase 3 clinical trials with over 1,400 patients evaluated, Tonmya was generally well tolerated. The most common adverse events (incidence \u22652%) included oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.<\/p>\n<hr>\n<p>Psychiatric Times is the connection to Psychiatry and Mental Health, featuring clinical updates, expert views, and research news in multimedia formats.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The US Food and Drug Administration (FDA) has approved Tonix Pharmaceuticals\u2019 Tonmya (cyclobenzaprine HCl, formerly known as TNX-102 SL), a novel treatment form for fibromyalgia.1 The drug is now the first in a new category of non-opioid analgesics for fibromyalgia and the first new medication for this disorder in 15 years. The FDA\u2019s approval cited [\u2026]<\/p>\n","protected":false},"author":534,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,47],"tags":[],"class_list":["post-220325","post","type-post","status-publish","format-standard","hentry","category-biotech-medical","category-neuroscience"],"_links":{"self":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/220325","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/users\/534"}],"replies":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/comments?post=220325"}],"version-history":[{"count":0,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/220325\/revisions"}],"wp:attachment":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/media?parent=220325"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/categories?post=220325"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/tags?post=220325"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}