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First new fibromyalgia drug in 15 years, Tonmya (cyclobenzaprine HCl) gains FDA approval and hits pharmacy shelves
05 Dec 2025 12:16 GMT
In a milestone moment for chronic pain management, Tonix Pharmaceuticals announced on August 15, 2025, that its novel sublingual therapy Tonmya has received approval from the U.S. Food and Drug Administration (FDA) - marking the first new drug for …
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Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder
24 Nov 2025 12:00 GMT
… biotechnology company, today announced the U.S. Food and Drug Administration (FDA … Chief Medical Officer of Tonix Pharmaceuticals. … treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine … clinical trials in …
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Judge reduces level of Pa. man’s homicide charges in drug overdose case
04 Dec 2025 22:45 GMT
… accused of providing the drug that killed a … following morning from “mixed drug toxicity,” Carlucci wrote.
… order are charges of drug delivery resulting in death … mixed drug toxicity, including cocaine, hydroxyzine, citalopram and cyclobenzaprine.
According …
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<![CDATA[November in Review: Updates on the Psychiatric Treatment Pipeline]]>
28 Nov 2025 17:36 GMT
… , clinically meaningful antidepressant effects, which …
Tonix Pharmaceuticals announced that Tonmya (cyclobenzaprine HCl … differences. Both medications target VMAT2 … Pharmaceutical has submitted a new drug application to the FDA for centanafadine for treatment …
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Tonix launches its new fibromyalgia drug in US
28 Nov 2025 10:45 GMT
… a lower dose of cyclobenzaprine than the pill formulations used to … FDA was based on two late-stage studies, in which the drug … a number of already-available treatment options for fibromyalgia, including … cyclobenzaprine, which is due to start a phase 2 trial …
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Tonix launches new oral fibromyalgia treatment
27 Nov 2025 13:14 GMT
Tonix Pharmaceuticals has launched Tonmya (cyclobenzaprine), a newly approved oral treatment for … patients. Across phase 3 trials, the drug significantly reduced patients’ daily … Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas …
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<![CDATA[Understanding Cyclobenzaprine Hydrochloride: An Emerging Therapy for Fibromyalgia]]>
27 Nov 2025 03:46 GMT
… , a tricyclic antidepressant, is conditionally … Pharmaceuticals Holding Corp) is a new sublingual formulation of cyclobenzaprine … .9
Clinical Trials
RELIEF (NCT04172831) … trial.13
Conclusion
Sublingual cyclobenzaprine HCl, a recently FDA-approved treatment …
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<![CDATA[FDA Clears Investigational New Drug Application for TNX-102 SL for Treatment of Major Depressive Disorder]]>
25 Nov 2025 07:33 GMT
… Drug Administration (FDA) has cleared the Investigational New Drug … (IDA) application for development of TNX-102 SL (cyclobenzaprine hydrochloride) for treatment … chief medical officer of Tonix Pharmaceuticals, … with traditional antidepressants like weight …
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Muscle Relaxant Drugs Market Expanding With $6.9 Billion at 7.8% CAGR by 2029
24 Nov 2025 00:45 GMT
… treatment strategies, management of chronic pain, innovations in pharmaceutical … adverse effects, individualized medicinal practices, studies in … struggle to swallow pills. The product … Drugs, Neuromuscular Blocking Agents
2) By Formulation: Cyclobenzaprine, …
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Tonix Pharma announces US commercial availability of Tonmya as a first-in-class fibromyalgia treatment
20 Nov 2025 12:01 GMT
… Pharmaceuticals Holding Corp., a fully integrated, commercial biotechnology company, announced that Tonmya (cyclobenzaprine … phase 3 trial, RESILIENT, was published in Pain Medicine with … bedtime treatment for fibromyalgia. Across both phase 3 trials, Tonmya …