Tonix Pharmaceuticals Presents Clinical Data on Tonmya™ for the Treatment of Fibromyalgia at PAINWEEK 2025
Tonix Pharmaceuticals (NASDAQ:TNXP) presented clinical data for Tonmya™, its recently FDA-approved treatment for fibromyalgia, at PAINWEEK 2025. The drug, approved on August 15, 2025, represents the first new FDA-approved fibromyalgia treatment in over 15 years.
The presentation included results from two pivotal Phase 3 trials (RELIEF and RESILIENT) demonstrating that Tonmya significantly reduced fibromyalgia pain compared to placebo. The drug showed consistent improvements across core symptoms, including widespread pain, sleep disturbance, and fatigue, while maintaining a favorable tolerability profile.
Tonmya works by targeting nonrestorative sleep through receptor antagonism that regulates sleep architecture. The company expects commercial availability in Q4 2025.
Tonix Pharmaceuticals (NASDAQ:TNXP) ha presentato a PAINWEEK 2025 i dati clinici relativi a Tonmya™, il suo trattamento recentemente approvato dalla FDA per la fibromialgia. Il farmaco, autorizzato il 15 agosto 2025, è la prima nuova terapia approvata dalla FDA per la fibromialgia in oltre 15 anni.
La presentazione ha incluso i risultati di due studi pivotali di Fase 3 (RELIEF e RESILIENT) che mostrano come Tonmya abbia ridotto in modo significativo il dolore da fibromialgia rispetto al placebo. Il farmaco ha mostrato miglioramenti coerenti nei sintomi principali, tra cui dolore diffuso, disturbi del sonno e affaticamento, mantenendo al contempo un profilo di tollerabilità favorevole.
Tonmya agisce indirizzando il sonno non ristoratore tramite l’antagonismo di recettori che regolano l’architettura del sonno. La società prevede la disponibilità commerciale nel 4º trimestre 2025.
Tonix Pharmaceuticals (NASDAQ:TNXP) presentó en PAINWEEK 2025 los datos clínicos de Tonmya™, su tratamiento recientemente aprobado por la FDA para la fibromialgia. El fármaco, aprobado el 15 de agosto de 2025, es la primera nueva terapia aprobada por la FDA para la fibromialgia en más de 15 años.
La exposición incluyó los resultados de dos ensayos pivotales de Fase 3 (RELIEF y RESILIENT) que demuestran que Tonmya redujo significativamente el dolor por fibromialgia frente a placebo. El fármaco mostró mejoras consistentes en los síntomas centrales, como el dolor generalizado, las alteraciones del sueño y la fatiga, manteniendo un perfil de tolerabilidad favorable.
Tonmya actúa abordando el sueño no reparador mediante el antagonismo de receptores que regulan la arquitectura del sueño. La compañía espera su disponibilidad comercial en el 4.º trimestre de 2025.
Tonix Pharmaceuticals (NASDAQ:TNXP)는 PAINWEEK 2025에서 자사의 최근 FDA 승인 섬유근육통 치료제 Tonmya™의 임상 데이터를 발표했습니다. 이 약은 2025년 8월 15일에 승인되었으며, FDA가 승인한 섬유근육통 신약으로는 15년 넘게 처음입니다.
발표에는 두 건의 주요 3상 임상시험(RELIEF 및 RESILIENT)의 결과가 포함되어 있으며, Tonmya는 위약 대비 섬유근육통 통증을 유의하게 감소시켰습니다. 약물은 전신 통증, 수면장애, 피로 등 핵심 증상 전반에서 일관된 개선을 보였고, 내약성 프로파일도 양호했습니다.
Tonmya는 수면 구조를 조절하는 수용체 길항작용을 통해 회복되지 않는 수면을 표적으로 작용합니다. 회사는 2025년 4분기에 상업적 공급을 기대하고 있습니다.
Tonix Pharmaceuticals (NASDAQ:TNXP) a présenté à PAINWEEK 2025 les données cliniques de Tonmya™, son traitement récemment approuvé par la FDA pour la fibromyalgie. Le médicament, approuvé le 15 août 2025, représente la première nouvelle thérapie approuvée par la FDA pour la fibromyalgie en plus de 15 ans.
La présentation a inclus les résultats de deux essais pivot de phase 3 (RELIEF et RESILIENT) montrant que Tonmya réduisait de manière significative la douleur liée à la fibromyalgie par rapport au placebo. Le médicament a montré des améliorations constantes des symptômes principaux, notamment la douleur généralisée, les troubles du sommeil et la fatigue, tout en conservant un profil de tolérance favorable.
Tonmya agit en ciblant le sommeil non réparateur via un antagonisme de récepteurs qui régulent l’architecture du sommeil. La société prévoit une disponibilité commerciale au 4e trimestre 2025.
Tonix Pharmaceuticals (NASDAQ:TNXP) stellte auf der PAINWEEK 2025 die klinischen Daten zu Tonmya™ vor, seinem kürzlich von der FDA zugelassenen Medikament gegen Fibromyalgie. Das Mittel, zugelassen am 15. August 2025, ist die erste neue von der FDA zugelassene Behandlung der Fibromyalgie seit über 15 Jahren.
Die Präsentation umfasste die Ergebnisse zweier wegweisender Phase-3-Studien (RELIEF und RESILIENT), die zeigen, dass Tonmya die Fibromyalgie-Schmerzen im Vergleich zu Placebo signifikant reduzierte. Das Medikament zeigte konsistente Verbesserungen bei den Kernsymptomen, darunter weit verbreitete Schmerzen, Schlafstörungen und Müdigkeit, und wies ein günstiges Verträglichkeitsprofil auf.
Tonmya wirkt, indem es nicht-erholsamen Schlaf adressiert: durch Rezeptorantagonismus, der die Schlafarchitektur reguliert. Das Unternehmen rechnet mit einer kommerziellen Verfügbarkeit im 4. Quartal 2025.
- First new FDA-approved fibromyalgia treatment in over 15 years
- Significant pain reduction demonstrated in two Phase 3 trials
- Favorable tolerability profile supporting long-term treatment potential
- Commercial launch on track for Q4 2025
- None.
Insights
Tonix's Tonmya, the first new fibromyalgia treatment in 15+ years, secured FDA approval with strong efficacy data and Q4 commercial launch timeline.
The FDA approval of Tonmya on August 15, 2025, represents a significant breakthrough in fibromyalgia treatment, addressing an unmet medical need in a market that hasn't seen innovation in over 15 years. The drug demonstrated consistent efficacy across two pivotal Phase 3 trials (RELIEF and RESILIENT), showing statistically significant pain reduction compared to placebo while maintaining a favorable safety profile – critical factors for regulatory approval and market adoption.
What's particularly noteworthy is Tonmya's novel mechanism targeting non-restorative sleep through receptor antagonism affecting sleep architecture. This approach addresses the multifaceted nature of fibromyalgia by improving not just pain, but also sleep disturbance and fatigue – core symptoms that significantly impact patient quality of life. This comprehensive symptom management could differentiate Tonmya from existing treatments.
From a commercial perspective, the Q4 2025 launch timeline gives Tonix minimal delay between approval and commercialization, optimizing patent protection runway. As the first new treatment option in this space since 2010, Tonmya enters a substantial market with approximately 4 million diagnosed fibromyalgia patients in the US alone. The non-opioid classification is particularly valuable given the ongoing concerns around opioid prescribing, potentially positioning Tonmya as a preferred first-line therapy option for clinicians.
Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years
Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo
Tonmya showed consistent improvements across core fibromyalgia symptoms, including widespread pain, sleep disturbance and fatigue
Tonmya was well tolerated, supporting its potential as a long-term treatment option for fibromyalgia
Tonmya is expected to be commercially available in the fourth quarter
CHATHAM, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, presented four posters at the PAINWEEK conference 2025, held September 2-5, 2025, in Las Vegas, Nevada entitled:
- “TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia”
- “Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials”
- “Steady-state Pharmacokinetic Properties of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL): Comparison to Simulations of Oral immediate-release CBP”
- “Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia”
“Fibromyalgia is a chronic and debilitating condition marked by widespread pain, poor sleep, and fatigue and cognitive dysfunction,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented at PAINWEEK show that Tonmya significantly improved pain with a favorable tolerability profile, offering patients and physicians a new, non-opioid treatment option. Now that Tonmya has been approved by FDA, we believe we are well-positioned to execute the launch and remain on track to deliver this drug to patients next quarter.”
The posters included data from two pivotal Phase 3 trials: RELIEF, a 14-week randomized, double-blind, placebo-controlled study of TNX-102 SL 5.6 mg (now Tonmya™), and RESILIENT, a confirmatory trial evaluating efficacy and safety. Across both studies, Tonmya significantly reduced fibromyalgia pain and demonstrated a favorable tolerability profile. By pharmacologically targeting nonrestorative sleep through antagonism of receptors that regulate sleep architecture, Tonmya engages a central mechanism believed to drive the persistence of fibromyalgia symptoms. The availability of a safe and well-tolerated treatment may also support earlier diagnosis and intervention, ultimately improving patient outcomes. Together, these findings suggest Tonmya has the potential to improve a broad spectrum of fibromyalgia symptoms.
Copies of the posters are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.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
About Tonmya™ (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 approved 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, RALLY and RESILIENT
The RELIEF and RESILIENT studies were double-blind, randomized, placebo-controlled trials designed to evaluate the efficacy and safety of Tonmya™ (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 Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for TonmyaTM, 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 and infectious diseases. 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). 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 infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to
* 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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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 Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599
Brian Korb
astr partners
brian.korb@astrpartners.com
(917) 653-5122
Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432
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 ≥
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 Pharmaceuticals (TNXP) receive FDA approval for Tonmya?
What clinical trials supported Tonmya's FDA approval for fibromyalgia?
How does Tonmya work to treat fibromyalgia symptoms?
When will Tonmya be available commercially for fibromyalgia patients?
What symptoms does Tonmya treat in fibromyalgia patients?
