Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that TONMYA™ (cyclobenzaprine HCl sublingual tablets) is now commercially available by prescription in U.S. pharmacies as of Nov 17, 2025. TONMYA is presented as a first‑in‑class, non‑opioid, once‑daily bedtime analgesic for adults with fibromyalgia and is the first FDA‑approved fibromyalgia treatment in more than 15 years.

The FDA approved TONMYA on Aug 15, 2025 based on two double‑blind Phase 3 trials (nearly 1,000 patients) showing a significant reduction in daily pain at 14 weeks and a higher percentage achieving ≥30% pain improvement; three Phase 3 trials (> 1,400 patients) reported overall tolerability and listed common adverse events.

Positive

• FDA approval on Aug 15, 2025
• Commercial availability in U.S. pharmacies as of Nov 17, 2025
• Two Phase 3 trials of nearly 1,000 patients showed significant pain reduction at 14 weeks
• Across three Phase 3 trials (> 1,400 patients) TONMYA was generally well tolerated

Negative

• Common adverse events reported (oral hypoesthesia, oral discomfort, abnormal taste, somnolence, fatigue)
• Adverse events incidence ≥2% higher in TONMYA-treated patients versus placebo

Insights

Clinical-commercial analyst

Tonix launched TONMYA, an FDA‑approved, first‑in‑class bedtime non‑opioid for fibromyalgia, now commercially available nationwide.

TONMYA received FDA approval on August 15, 2025 and is available by prescription as of November 17, 2025. The approval rests on two randomized, double‑blind, placebo‑controlled Phase 3 trials (nearly 1,000 patients) showing significant reductions in daily pain at 14 weeks and a higher share of patients achieving a clinically meaningful 30% or greater pain improvement at three months. The company also reports three Phase 3 trials (over 1,400 patients) indicating generally good tolerability, with the most common adverse events being oral sensory effects, somnolence, fatigue and dry mouth.

Clinically, a once‑daily bedtime non‑opioid that demonstrates statistically significant pain reduction and a meaningful responder rate addresses an established unmet need given there had been no new FDA approvals for fibromyalgia in more than 15 years. Key dependencies and risks include real‑world tolerability of oral sensory and sedation effects, payer coverage decisions, and the company’s ability to scale commercial distribution and physician adoption. Watch regulatory and market signals over the next 6–12 months, specifically formulary placements, prior‑authorization requirements, and early real‑world safety/tolerability reports from prescribing clinicians.

TONMYA is now available by prescription and available for pharmacy ordering nationwide

TONMYA is the first FDA-approved treatment for fibromyalgia in more than 15 years

TONMYA is a unique, non-opioid, once-daily bedtime analgesic that significantly reduces fibromyalgia pain and is generally well-tolerated

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 TONMYA^TM (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 TONMYA^TM (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-HT_2A 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 TONMYA^TM (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

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
TONMYA is contraindicated:

• In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
• With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
• During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
• In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS

• Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
• Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
• Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
• Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
• CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
• Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS

• MAO inhibitors: Life-threatening interactions may occur.
• Other serotonergic drugs: Serotonin syndrome has been reported.
• CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
• Tramadol: Seizure risk may be enhanced.
• Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
  

USE IN SPECIFIC POPULATIONS

• Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
• Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
• Pediatric use: The safety and effectiveness of TONMYA have not been established.
• Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
• Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
  

Please see additional safety information in the full Prescribing Information.

To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: Tonix Pharmaceuticals Holding Corp.

Released November 17, 2025

FAQ

When did Tonix (TNXP) receive FDA approval for TONMYA and when is it available?

The FDA approved TONMYA on Aug 15, 2025, and it became commercially available in U.S. pharmacies on Nov 17, 2025.

What evidence supported TONMYA approval for fibromyalgia (TNXP)?

Approval incorporated two double‑blind Phase 3 trials (~1,000 patients) showing significant daily pain reduction at 14 weeks and a greater percentage with ≥30% pain improvement.

How is TONMYA administered and what is the dosing schedule for fibromyalgia (TNXP)?

TONMYA is a sublingual tablet taken once daily at bedtime as a non‑opioid analgesic for adults with fibromyalgia.

What safety and tolerability data were reported for TONMYA (TNXP)?

Across three Phase 3 trials (> 1,400 patients), TONMYA was generally well tolerated; common adverse events included oral hypoesthesia, oral discomfort, abnormal taste, somnolence, fatigue, dry mouth, and aphthous ulcer.

How many people could potentially benefit from TONMYA in the U.S. (TNXP)?

Tonix estimates about 10 million people in the U.S. are living with fibromyalgia who may be candidates for treatment.

Where can clinicians find more prescribing information for TONMYA (TNXP)?

Prescribers and clinicians can find additional information at TonmyaHCP.com.