Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP 8-K
Tonix Pharmaceuticals Presented Post Hoc Analyses
of Phase 3 Data on TONMYATM at the 8th International Congress on Controversies in Fibromyalgia
Company launched TONMYA, approved by the FDA
as a treatment for fibromyalgia, in November 2025
In post hoc analysis of the pivotal RESILIENT
study, TONMYA produced rapid pain relief as early as Day 2 of treatment, with durable pain reduction and significant improvements in all
key secondary endpoints as compared to placebo
In pooled post hoc analysis of the pivotal
RELIEF and RELISIENT studies, TONMYA showed favorable benefit-risk profile using number needed to treat, number needed to harm, and likelihood
to be helped or harmed
BERKELEY HEIGHTS, N.J., March 10 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals
Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company,
announced two oral presentations on TONMYATM, which was investigated as TNX-102 SL (cyclobenzaprine HCl sublingual tablets)
at the 8th International Congress on Controversies in Fibromyalgia held on March 9-10, 2026, in Krakow, Poland.
"Phase 3 post hoc analyses reinforce the potential of
TONMYA to provide a benefit to the approximately 10 million adults in the U.S. living with fibromyalgia," said Gregory Sullivan,
M.D., Chief Medical Officer of Tonix Pharmaceuticals. "In a post hoc analysis of RESILIENT, the data show rapid and early
onset of pain relief. In a post hoc analysis of two pivotal studies, TONMYA showed a favorable benefit-risk profile that suggests
treatment benefit is nearly four times more likely than discontinuation of treatment due to an adverse event. Together, these findings
underscore TONMYA's profile as a differentiated, generally well tolerated, and effective medicine that may address the unmet medical
needs of those with fibromyalgia. TONMYA is the first medication approved for fibromyalgia in over 15 years."
Oral Presentation One: "Cyclobenzaprine HCl Sublingual Tablets
(CBP SL) Provide Rapid Pain Relief in Adults with Fibromyalgia"
In the RESILIENT trial, a 14-week, randomized, placebo-controlled
Phase 3 study evaluating 457 adults with fibromyalgia as defined by 2016 American College of Rheumatology (ACR) criteria, a post hoc
mixed-model repeated-measures analysis demonstrated that TONMYA produced a rapid reduction in pain, with improvements versus placebo observed
as early as Day 2 of treatment and statistically significant pain relief at each week over Weeks 1-14. The primary endpoint, change
from baseline to Week 14 in weekly average daily numeric rating scale (NRS) pain scores, was met with high statistical significance (p<0.001),
with a least-squares mean treatment difference of -0.65. All key secondary endpoints were also statistically significant in favor of TONMYA.
TONMYA was generally well tolerated, with 6.1% of participants discontinuing
due to adverse events versus 3.5% with placebo. The most common treatment-emergent adverse events were oral cavity reactions, including
oral hypoesthesia (23.8%) and abnormal product taste (11.7%), which were typically mild, transient, and self-limited.
Oral Presentation Two: "Cyclobenzaprine HCl Sublingual Tablets
for the Treatment of Fibromyalgia: Number Needed to Treat and Number Needed to Harm"
The data from a pooled post hoc analysis of 959 participants (783
completed the studies) from the RELIEF and RESILIENT Phase 3 trials was utilized to further clarify the benefit-risk profile of TONMYA
using number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH). The NNT for achieving a
clinically meaningful 30% pain reduction over placebo at Week 14 was 7 (95% confidence interval (CI): 5-12) while the NNH for
discontinuation due to an adverse event was 26 (95% CI: 14-110). Based on these values, the LHH was 3.7, indicating that TONMYA
provides a nearly four-fold greater likelihood of clinical benefit than adverse event-related discontinuation.
The pooled safety data were consistent with the known profile of
TONMYA, with no new or unexpected safety signals. The most common treatment-emergent adverse events were oral cavity reactions that were
typically mild, transient, and self-limited.
Copies of the Company's presentations are available under the
Scientific Presentations tab on the Tonix website at www.tonixpharma.com.
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 6-12 million adults in
the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, 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.
Physicians and patients report common dissatisfaction with currently marketed products.
About TONMYA (cyclobenzaprine HCl sublingual tablets)
TONMYA (cyclobenzaprine HCl sublingual tablets) 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 multifunctional agent with potent binding
and antagonist activities at the 5-HT2A serotonergic, 1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA was approved
on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for
fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress reaction
(ASR)/acute stress disorder (ASD), and major depressive disorder (MDD). 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. 10,357,465 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 TONMYA composition. These patents are expected to provide TONMYA
with U.S. market exclusivity until 2034/2035.
Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals* is a fully-integrated, commercial-stage
biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYATM
(cyclobenzaprine HCl sublingual tablets 2.8mg), the Company's recently approved flagship medicine, is the first new treatment for
fibromyalgia in more than 15 years. Tonix's CNS commercial infrastructure supports its marketed products, including its acute migraine
products, Zembrace SymTouch and Tosymra . Tonix is maximizing the science behind TONMYA
in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company's
CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing
a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation
CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company
* 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.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines.
Forward Looking Statements
Certain statements in this press release are forward-looking within
the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction
of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. 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 as a result of a number of factors, including the ability of the Company
to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company's Annual
Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 18, 2025, and periodic reports filed with the
SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. 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.
Tonix Pharmaceuticals
Tonix Pharmaceuticals
TONMYA is indicated for the treatment of fibromyalgia in adults.
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