Tonix Pharmaceuticals Announces Positive Pre-NDA CMC Meeting with FDA for Tonmya™ for the Management of Fibromyalgia
June 20 2024 - 8:00AM
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) Type-B Chemistry, Manufacturing, and Controls
(CMC) meeting with the U.S. Food and Drug Administration (FDA) for
Tonmya™ for the management of fibromyalgia. The purpose of the
meeting was to seek alignment and agreement with the FDA on key CMC
topics to support a planned NDA submission for Tonmya for the
management of fibromyalgia. Based on formal written feedback, the
Company believes it is aligned with the FDA on key topics,
including proposed drug substance and drug product commercial
specifications, shelf life assignment, manufacturing and commercial
drug packaging.
In addition, the Company has completed the
second and final pre-NDA meeting for Tonmya with the FDA and
discussed nonclinical, clinical pharmacology and clinical matters.
The Company awaits formal minutes after which it expects to
announce the results of that meeting. The Company remains on track
to submit the NDA for Tonmya for the management of fibromyalgia to
the FDA in the second half of 2024.
“We remain encouraged and excited about the
prospect of bringing the first new treatment to market for
fibromyalgia patients in over a decade, and this encouraging
meeting with the FDA is an important milestone as we head into the
final stages of completion of the NDA package,” said Seth Lederman,
M.D., Chief Executive Officer of Tonix Pharmaceuticals. “During the
pre-NDA CMC meeting, the FDA affirmed alignment with Tonix on CMC
content and commercial strategy for Tonmya, and we are very
appreciative of the FDA’s guidance as we prepare for our NDA
submission. We are currently actively preparing a dual
manufacturing launch strategy with global contract development and
manufacturing organization (CDMO) Almac Pharma Services and another
CDMO.”
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, 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* (also known as TNX-102 SL)
Tonmya is a centrally acting, non-opioid,
non-addictive, bedtime medication. 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.
*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 Pharmaceuticals Holding
Corp.*
Tonix is a 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 Tonmya1, 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 FDA Breakthrough Therapy designation that is
in Phase 2 development and is supported by a grant from the
National Institute of Drug Abuse. 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.
*Tonix’s product development candidates are
investigational new drugs or biologics and have not been approved
for any indication.
1Tonmya™ is conditionally accepted by the U.S.
Food and Drug Administration (FDA) as the tradename for TNX-102 SL
for the management of fibromyalgia. Tonmya has 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, 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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