November 17, 2025 7:00am EST
CHATHAM, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced today that TONMYATM (cyclobenzaprine HCl sublingual tablets) is now commercially available at pharmacies by prescription in the United States. TONMYA is a first-in-class treatment for fibromyalgia in adults as a non-opioid analgesic taken once daily at bedtime.
“The availability of TONMYA is a momentous day for Tonix, providing the estimated 10 million people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “After more than 15 years without innovation for this disease, we are honored to bring this new treatment option to patients in partnership with the full fibromyalgia community including researchers, patients, and investigators. We are excited and motivated to make TONMYA accessible to as many patients as possible.”
The latest Phase 3 trial, RESILIENT, was published in Pain Medicine with data on primary endpoints measuring pain, and secondary endpoints measuring patient’s global impression of change, patient-reported symptoms and function, sleep disturbance, and fatigue.
“For years, fibromyalgia patients have struggled with limited treatment options that often fall short. The availability of TONMYA marks a meaningful advancement by targeting neurotransmitters thought to be involved in fibromyalgia,” said Andrea L. Chadwick, M.D., MSc, FASA, Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System.
“We’re truly excited about this new option for people living with fibromyalgia,” said Sharon Waldrop, a person with lived experience and founder of the Fibromyalgia Association. “The availability of TONMYA provides new hope for our community and represents a crucial step forward in fibromyalgia treatment.”
TONMYA was approved by the FDA on August 15, 2025.
The approval incorporated efficacy from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients in total that evaluated TONMYA as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, TONMYA significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking TONMYA experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo.
Across three Phase 3 clinical trials with over 1,400 patients evaluated, TONMYA was generally well tolerated. The most common adverse events (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) included oral hypoesthesia (numbness in the mouth), oral discomfort, abnormal product taste, somnolence (drowsiness), oral paresthesia (tingling, pricking or burning in the mouth), oral pain, fatigue, dry mouth, and aphthous ulcer (canker sore).
For more information, visit TonmyaHCP.com
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 10 million adults in the U.S., approximately 80% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep (waking up tired and unrefreshed), fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Patients with fibromyalgia have double the medical costs compared to the general population in the U.S.
About TONMYATM (cyclobenzaprine HCl sublingual tablets)
TONMYA, which was investigated as TNX-102 SL, is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA is now commercially available as a once-daily bedtime treatment for fibromyalgia in adults. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.
About the Phase 3 Clinical Trials: RELIEF and RESILIENT
The RELIEF and RESILIENT studies were double-blind, randomized, placebo-controlled trials designed to evaluate the efficacy and safety of TONMYATM (cyclobenzaprine hydrochloride sublingual tablets) for the treatment of fibromyalgia. RELIEF and RESILIENT were two-arm trials that enrolled 503 and 457 adults with fibromyalgia across 40 and 33 United States sites, respectively. In both trials, the first two weeks of treatment consisted of a run-in period in which participants started on TONMYA 2.8 mg (1 tablet) or placebo. Thereafter, all participants increased their dose to TONMYA 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint across both trials was the daily diary pain intensity score change (TONMYA 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores). Additional details on RELIEF (NCT04172831) and RESILIENT (NCT05273749) are available on clinicaltrials.gov.
RALLY was a replicate Phase 3 trial to RELIEF and RESILIENT that demonstrated greater but non-significant treatment effect with TONMYA compared to placebo and demonstrated consistent safety. Results of this trial may not have been generalizable due to the presence of factors outside the conduct of the study. Additional details are available on clinicaltrials.gov (NCT04508621).
Tonix Pharmaceuticals Holding Corp.
Tonix is a fully integrated, commercial-stage biotechnology company. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, infectious and rare diseases. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, Inc., a wholly owned commercial subsidiary, markets treatments for fibromyalgia and acute migraine.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Investor Contacts
Mary Ann Ondish
Tonix Pharmaceuticals
(862) 799-8599
investor.relations@tonixpharma.com
Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com
Media Contact
Meagen Hagans
Weber Shandwick
(757)358-2033
MHagans@webershandwick.com
