Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya™ as Trade Name for TNX-102 SL for the Management of Fibromyalgia
29 Janeiro 2024 - 9:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a biopharmaceutical company with marketed products and a
pipeline of development candidates, today announced that the U.S.
Food and Drug Administration (FDA) has conditionally accepted the
trade name, Tonmya™, for the Company's drug product candidate
TNX-102 SL for the management of fibromyalgia.
Tonmya is a patented sublingual tablet
formulation of cyclobenzaprine hydrochloride developed for the
management of fibromyalgia. In December 2023, the Company announced
highly statistically significant and clinically meaningful topline
results in RESILIENT, a second positive Phase 3 clinical trial of
Tonmya for the management of fibromyalgia. In the study, Tonmya met
its pre-specified primary endpoint, significantly reducing daily
pain compared to placebo (p=0.00005) in participants with
fibromyalgia. Statistically significant and clinically meaningful
results were also seen in all key secondary endpoints related to
improving sleep quality, reducing fatigue and improving overall
fibromyalgia symptoms and function. RELIEF, the first positive
Phase 3 trial of Tonmya in fibromyalgia, was completed in December
2020. It met its pre-specified primary endpoint of daily pain
reduction compared to placebo (p=0.010) and showed activity in key
secondary endpoints. Tonix plans to have a pre-NDA meeting with
U.S. Food and Drug Administration (FDA) in the first half of 2024
and to submit a New Drug Application (NDA) to the FDA in the second
half of 2024 for Tonmya for the management of fibromyalgia.
“We are very pleased with the FDA’s conditional
acceptance of Tonmya as the brand name for TNX-102 SL,” said Seth
Lederman, M.D., President and Chief Executive Officer of Tonix
Pharmaceuticals. “With this acceptance, we remain excited for what
we believe is an important opportunity to offer the first
FDA-approved drug for fibromyalgia patients in more than a
decade.”
About Tonmya™ (formerly known as TNX-102
SL)
Tonmya is a patented sublingual tablet
formulation of cyclobenzaprine hydrochloride which is designed for
daily administration at bedtime with a proposed mechanism of
improving sleep quality in fibromyalgia. Tonmya 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,
α1-adrenergic, H1-histaminergic, and M1-muscarinic cholinergic
receptors, Tonmya is in development as a daily bedtime treatment
for fibromyalgia, fibromyalgia-type Long COVID (formally known as
post-acute sequelae of COVID-19 [PASC]), 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. 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, upon NDA approval, with U.S. market
exclusivity until 2034/2035. In addition, Tonix has pending but not
issued U.S. patent applications directed to the transmucosal
absorption of CBP-HCl, with U.S. market exclusivity expected until
2033, for treating depressive symptoms in fibromyalgia, with U.S.
market exclusivity expected until 2032, and for treating pain in
fibromyalgia with U.S. market exclusivity expected until 2041.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a biopharmaceutical company focused on
commercializing, developing, discovering and licensing therapeutics
to treat and prevent human disease and alleviate suffering. Tonix’s
development portfolio is focused on central nervous system
disorders. Tonix’s priority is to submit a New Drug Application
(NDA) to the FDA for Tonmya, which has completed two positive Phase
3 studies for the management of fibromyalgia. Tonix intends to meet
with the FDA in the first half of 2024 and submit an NDA for the
approval of Tonmya for the management of fibromyalgia in the second
half of 2024. TNX-102 SL is being developed to treat
fibromyalgia-type Long COVID, a chronic post-acute COVID-19
condition, and topline results from a proof-of-concept study were
reported in the third quarter of 2023. TNX-1300 (cocaine esterase)
is a biologic designed to treat cocaine intoxication and has been
granted Breakthrough Therapy designation by the FDA. A Phase 2
study of TNX-1300 is expected to be initiated in the first quarter
of 2024. Tonix’s rare disease development portfolio includes
TNX-2900 (intranasal potentiated oxytocin) for the treatment of
Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug
designation by the FDA and an investigational new drug (IND)
application has been cleared to support a Phase 2 study in PWS
patients. Tonix’s immunology development portfolio includes
biologics to address organ transplant rejection, autoimmunity and
cancer, including TNX-1500, which is a humanized monoclonal
antibody targeting CD40-ligand (CD40L or CD154) being developed for
the prevention of allograft rejection and for the treatment of
autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in
the third quarter of 2023. Tonix’s infectious disease pipeline
includes TNX-801, a vaccine in development to prevent smallpox and
mpox. TNX-801 also serves as the live virus vaccine platform or
recombinant pox vaccine platform for other infectious diseases,
including TNX-1800, in development as a vaccine to protect against
COVID-19. During the fourth quarter of 2023, TNX-1800 was selected
by the U.S. National Institutes of Health (NIH), National Institute
of Allergy and Infectious Diseases (NIAID) Project NextGen for
inclusion in Phase 1 clinical trials. The infectious disease
development portfolio also includes TNX-3900 and TNX-4000, which
are classes of broad-spectrum small molecule oral antivirals. Tonix
Medicines, our commercial subsidiary, markets Zembrace® SymTouch®
(sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray)
10 mg under a transition services agreement with Upsher-Smith
Laboratories, LLC from whom the products were acquired on June 30,
2023. Zembrace SymTouch and Tosymra are each indicated for the
treatment of acute migraine with or without aura in adults.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
Zembrace SymTouch and Tosymra are registered
trademarks of Tonix Medicines. All other marks are property of
their respective owners.
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, 2022, as filed
with the Securities and Exchange Commission (the “SEC”) on March
13, 2023, 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 MorrisTonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (862)
904-8182
Peter VozzoICR Westwickepeter.vozzo@westwicke.com (443)
213-0505
Media Contact
Ben ShannonICR
Westwickeben.shannon@westwicke.com443-213-0495
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