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PHARMACEUTICALS HOLDING CORP. 8-K
Pharmaceuticals Announces Positive Pre-IND Meeting with FDA for TNX-102 SL for the Treatment of Major Depressive Disorder
anticipates filing the IND application in the fourth quarter of 2025
SL is a potential first-in-class treatment for targeting the disturbed sleep associated with depression
SL is FDA-approved for the treatment of fibromyalgia
September 18, 2025 - Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with
marketed products and a pipeline of development candidates, today announced the successful completion of a Type B Pre-Investigational
New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of TNX-102 SL (sublingual cyclobenzaprine
HCl) for the treatment of major depressive disorder (MDD). The Company received positive feedback from the FDA and plans to pursue a
supplemental new drug application (sNDA) to expand the therapeutic indication of TNX-102 SL to include MDD, based on exploratory findings
suggesting that improving sleep quality may positively impact depressive symptoms.
pleased with the outcome of our Pre-IND meeting with the FDA and appreciate their thoughtful guidance," said Seth Lederman, M.D.,
Chief Executive Officer of Tonix Pharmaceuticals. "This marks a significant step forward in our efforts to develop TNX-102 SL as
a novel treatment for MDD, a condition that affects millions and remains underserved by current therapies that are often difficult to
bedtime TNX-102 SL has the potential to be a first-in-class treatment that is designed to target the reduced quality and quantity of
slow wave sleep associated with depression," said Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. "TNX-102
SL is a tertiary amine tricyclic that is designed for transmucosal absorption to bypass first pass hepatic metabolism. In contrast, FDA-approved
tertiary amine tricyclic antidepressants are swallowed pill formulations, that are largely metabolized by first-pass to longer-lived
secondary amine tricyclics. Also, the FDA-approved tertiary amine tricyclic antidepressants are only active in treating MDD at more than
ten times the dose employed with TNX-102 SL and can adversely impact weight, blood pressure, cognition, and sexual function."
constructive feedback during the Pre-IND meeting for TNX-102 SL in MDD and found the proposed long-term safety data collection plan generally
reasonable, potentially streamlining the development path.
is planned for Q4 2025, positioning the program to enter Phase 2 clinical trials shortly thereafter. TNX-102 SL is FDA approved for the
treatment of fibromyalgia, under the brand name TonmyaTM. In the Phase 3 RESILIENT study of fibromyalgia patients, the TNX-102
SL - treated group had activity on improving depression over placebo by the Beck Depression Inventory (BDI), with an uncorrected
p-value < 0.05. The biological relationship between depressed symptoms in fibromyalgia and those in MDD is not understood.
a patented sublingual tablet formulation of cyclobenzaprine hydrochloride that enables rapid transmucosal absorption and reduces production
of the long half-life active metabolite, norcyclobenzaprine, by bypassing first-pass hepatic metabolism. As a tertiary amine tricyclic
(TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, 1-adrenergic, H1-histaminergic,
and M1-muscarinic receptors. It is currently approved in the U.S. as a once-daily bedtime treatment for fibromyalgia in adults.
TNX-102 SL is also in development as a daily bedtime treatment for acute stress reaction/acute stress disorder. Tonix also holds active
IND's for the following indications for TNX-102 SL: Long COVID (post-acute sequelae of COVID-19), PTSD, alcohol use disorder, and
agitation in Alzheimer's disease. 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.
Tonix Pharmaceuticals
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 $34 million over five years. TNX-4200 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.
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.
and further information about Tonix can be found at www.tonixpharma.com.
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 failure to successfully launch
and commercialize Tonmya and any of our approved 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.
Tonix Pharmaceuticals
for the treatment of fibromyalgia in adults.
TONMYA is contraindicated:
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.
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.
recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart
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.
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