Tonix Pharmaceuticals Reports Final Positive Pre-NDA Meeting with FDA for Tonmya™ for the Management of Fibromyalgia
2024年7月8日 - 9:00PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates, today
announced receipt of the formal minutes from a recent pre-New Drug
Application (NDA) meeting with the U.S. Food and Drug
Administration (FDA) for Tonmya™ (cyclobenzaprine HCl sublingual
tablets) for the management of fibromyalgia. At the meeting, the
Company and the FDA agreed that the proposed data package is
sufficient to support the NDA submission. The Company reaffirmed
its guidance to submit the NDA for Tonmya to the FDA in the second
half of 2024 which would allow for a potential FDA approval in the
second half of 2025.
“We are delighted with the results of this
critical milestone meeting with the FDA to discuss our NDA, and we
are appreciative of the FDA’s guidance throughout this process. We
believe Tonmya has the potential to greatly benefit fibromyalgia
patients, many of whom remain dissatisfied with the current
treatment options, and many of whom turn to addictive, detrimental
opioids as off-label treatments,” said Seth Lederman, M.D., Chief
Executive Officer of Tonix Pharmaceuticals. “The positive results
from this pre-NDA meeting underscore the completeness of our data
package in support of registration of Tonmya for the management of
fibromyalgia.”
On June 20, 2024, Tonix announced receipt of
formal minutes of a pre-NDA Type-B Chemistry, Manufacturing, and
Controls (CMC) meeting confirming alignment with the FDA on key CMC
topics to support the NDA submission. Today’s announcement confirms
alignment with the nonclinical, clinical pharmacology and clinical
features of the NDA submission, following completion of Tonix’s
second and final pre-NDA meeting.
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 6 million to 12 million adults in the U.S., the majority
of whom are women. Symptoms of fibromyalgia include chronic
widespread pain, non-restorative sleep, fatigue, and brain fog (or
cognitive dysfunction). Other associated symptoms include mood
disturbances, including anxiety and depression, headaches, and
abdominal pain or cramps. 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. According
to the recent report from the U.S. National Academies of Sciences,
fibromyalgia is a diagnosable condition that may also occur in the
context of Long COVID.1
About Tonmya* (also known as TNX-102 SL)
Tonmya is a centrally acting, non-opioid,
non-addictive, bedtime investigational drug. The tablet is a
patented sublingual 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, the second pivotal 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 six key secondary
endpoints related to improving sleep quality, reducing fatigue and
improving overall fibromyalgia symptoms and function. RELIEF, the
first statistically significant 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.
In both pivotal studies, the most common treatment-emergent adverse
event was tongue or mouth numbness at the administration site,
which was temporally related to dosing, self-limited, never rated
as severe, and rarely led to study discontinuation (one participant
in each study).
Tonix Pharmaceuticals Holding
Corp.**
Tonix is a fully-integrated biopharmaceutical
company focused on developing, licensing and commercializing
therapeutics to treat and prevent human disease and alleviate
suffering. Tonix’s development portfolio is focused on central
nervous system (CNS) disorders. Tonix’s priority is to submit a New
Drug Application (NDA) to the FDA in the second half of 2024 for
Tonmya, a product candidate for which two statistically significant
Phase 3 studies have been completed for the management of
fibromyalgia. TNX-102 SL is also being developed to treat acute
stress reaction as well as fibromyalgia-type Long COVID. Tonix’s
CNS portfolio includes TNX-1300 (cocaine esterase), a biologic
designed to treat cocaine intoxication that has Breakthrough
Therapy designation. Tonix’s immunology development portfolio
consists of 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. Tonix also has product candidates
in development in the areas of rare disease and infectious disease.
Tonix Medicines, our commercial subsidiary, markets Zembrace®
SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan
nasal spray) 10 mg for the treatment of acute migraine with or
without aura in adults.
*Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration as the tradename for TNX-102 SL for
the management of fibromyalgia. Tonmya has not been approved for
any indication.
**Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
1U.S. National Academies of Sciences,
Engineering, and Medicine. 2024. A Long COVID Definition: A
chronic, systemic disease state with profound consequences.
Washington, DC: The National Academies Press.
https://doi.org/10.17226/27768.
http://www.nationalacademies.org/long-covid-definition.
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, 2023, as filed
with the Securities and Exchange Commission (the “SEC”) on April 1,
2024, 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
Katie
DodgeLaVoieHealthSciencekdodge@lavoiehealthscience.com(978)
360-3151
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から 7 2023 まで 7 2024