Tonix Pharmaceuticals Presented Data on Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2025 American College of Rheumatology (ACR) Convergence

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) presented Phase 3 RESILIENT data showing statistically significant pain reduction (p<0.0001) with Tonmya (cyclobenzaprine HCl sublingual tablets) versus placebo in adults with fibromyalgia.

The 14-week, randomized, double-blind trial enrolled 456 intent-to-treat participants across 34 U.S. sites. Tonmya also produced meaningful improvements in sleep, fatigue, and fibromyalgia symptoms/function, and exploratory analyses showed sexual function gains in female participants.

Tonmya was FDA approved on August 15, 2025. Safety findings included low adverse event–related discontinuations (6.1% on Tonmya vs 3.5% placebo) and mostly mild oral mucosal reactions; labeled risks include embryofetal toxicity and serotonin syndrome drug interactions.

Positive

• Pain reduction statistically significant (p<0.0001)
• FDA approval granted on August 15, 2025
• 456 participants in Phase 3 RESILIENT trial
• Improvements in sleep and fatigue scores

Negative

• Oral mucosal adverse reactions were the most common side effects
• Label includes embryofetal toxicity risk from animal data
• Risk of serotonin syndrome with many concomitant drugs
• No clinical trial data for patients 65 years and older

Insights

Clinical-commercial analyst

Phase 3 RESILIENT shows statistically significant pain relief and a favorable tolerability profile for Tonmya, supporting its recent FDA approval.

Tonmya demonstrated a statistically significant reduction in weekly average pain at Week 14 (p<0.0001) in the 456-participant, 14-week randomized double-blind RESILIENT trial across 34 U.S. sites, with concurrent improvements in sleep, fatigue, and Fibromyalgia Impact Questionnaire domains. The trial reported low impact on weight and blood pressure, no adverse sexual side effects, and common adverse events confined largely to mild, self-limited oral mucosal reactions. Discontinuation rates were comparable: overall discontinuation 19% on Tonmya vs 20.8% on placebo; adverse event-related discontinuations were 6.1% vs 3.5%.

The business mechanism is straightforward: a centrally acting, non-opioid analgesic with a bedtime sublingual formulation that produced clinically measurable symptom relief in a Phase 3 study. Key dependencies and risks remain regulatory implementation, real-world tolerability versus the trial population, and uptake by prescribers given labeled contraindications (e.g., MAO inhibitors, certain cardiac conditions) and warnings about serotonin syndrome and CNS depression. Medication interactions and special-population limits (no trial subjects ≥65 years) narrow eligible use.

Watch for near-term commercial milestones and uptake signals now that the product received FDA approval on August 15, 2025: formulary decisions, payer coverage policies, real-world safety reporting (oral mucosal reactions, CNS effects), and prescribing patterns in females given the exploratory sexual-function signal. Expect these items to clarify commercial impact within the next 6–18 months.

Tonmya demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study

Treatment was well tolerated with minimal effects on weight or blood pressure and discontinuation rate of 19% vs. placebo of 20.8%

Data support the potential of Tonmya as a well-tolerated, centrally acting, non-opioid analgesic and therapeutic option for adults with fibromyalgia

CHATHAM, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated commercial biotechnology company presented data on Tonmya™, which was investigated as TNX-102 SL, at the 2025 American College of Rheumatology (ACR) Convergence, held October 24–29, 2025, in Chicago, Illinois. A copy of the Company’s presentation, titled “TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia,” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

“Fibromyalgia is a debilitating condition that impacts more than 10 million adults in the U.S., and existing treatments are limited by tolerability and side effects,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented at ACR highlight Tonmya’s ability to provide clinically meaningful pain reduction while remaining well-tolerated, reinforcing its value as a differentiated, centrally-acting non-opioid treatment for fibromyalgia.”

The data presented at ACR come from RESILIENT, a 14-week randomized, double blind, placebo controlled trial at 34 U.S. sites, with 456 intent-to-treat participants who met the 2016 American College of Rheumatology criteria for fibromyalgia. Treatment with Tonmya resulted in a statistically significant reduction in weekly average pain scores at Week 14 (p<0.0001) versus placebo, along with significant improvements in sleep quality and fatigue as well as the symptoms and function domains of the Fibromyalgia Impact Questionnaire. In an exploratory analysis, among female participants, Tonmya was associated with improvements in sexual function in total score and across multiple subscales of the Changes in Sexual Functioning Questionnaire (CSFQ-14) versus placebo. Tonmya was well tolerated, with minimal impact on weight and blood pressure, no adverse sexual side effects and a low rate of adverse event-related discontinuations (6.1% on Tonmya, 3.5% on placebo). The most common adverse events were mild and self-limited oral cavity reactions that rarely led to study withdrawal.

“The results from RESILIENT further support Tonmya’s role as an innovative treatment option that addresses chronic and widespread pain, one of the most burdensome symptoms of fibromyalgia,” added Gregory M. Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Tonmya’s favorable tolerability profile and unique formulation designed for bedtime sublingual administration offer patients and clinicians an important advancement in care.”

Tonmya was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults.

Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for Tonmya, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a monoclonal antibody for the seasonal prevention of Lyme Disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

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
Jessica Morris 
Tonix Pharmaceuticals 
investor.relations@tonixpharma.com 
(862) 799-8599 

Brian Korb 
astr partners 
(917) 653-5122 
brian.korb@astrpartners.com 

Media Contact 
Ray Jordan 
Putnam Insights 
ray@putnaminsights.com 
 

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

FAQ

When did Tonix (TNXP) receive FDA approval for Tonmya?

Tonmya received FDA approval on August 15, 2025 for treatment of fibromyalgia in adults.

What were the RESILIENT Phase 3 trial results for Tonmya (TNXP)?

The 14-week RESILIENT trial (n=456) showed a statistically significant weekly average pain reduction at Week 14 (p<0.0001) versus placebo.

What safety findings did Tonix report for Tonmya (TNXP) in RESILIENT?

Tonmya had mostly mild oral mucosal reactions; adverse event–related discontinuations were 6.1% on Tonmya versus 3.5% on placebo.

Does Tonmya (TNXP) affect sleep, fatigue, or sexual function in fibromyalgia patients?

RESILIENT reported significant improvements in sleep and fatigue, and an exploratory analysis showed sexual function improvements in female participants.

What important warnings are included in the Tonmya label for TNXP investors?

Label warnings include potential embryofetal toxicity (animal data), risk of serotonin syndrome with many drugs, and tricyclic-like cardiac risks.

Where can investors find Tonix’s ACR 2025 presentation for Tonmya (TNXP)?

The company posted the ACR presentation under Scientific Presentations on Tonix’s website at www.tonixpharma.com.