Tonix Pharmaceuticals Granted Fast Track Designation by FDA for Tonmya™ for Fibromyalgia
25 Luglio 2024 - 2:00PM
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 that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation to Tonmya™ (cyclobenzaprine HCl
sublingual tablets) for the management of fibromyalgia. Tonmya is a
non-opioid, centrally-acting analgesic drug under development for
treating fibromyalgia, which is a common chronic pain condition
affecting mostly women. The designation validates that fibromyalgia
is a serious condition and that Tonmya has the potential to address
this unmet medical need. Tonix previously announced alignment with
the FDA regarding the content of its proposed NDA submission,
following completion of the Company’s pre-NDA meetings. The Company
reaffirms its guidance to submit the NDA for Tonmya to the FDA in
the second half of 2024.
“The FDA’s decision to grant Tonmya Fast Track
designation supports our goal of bringing this well tolerated,
non-opioid analgesic treatment option to the market in 2025,” said
Seth Lederman, M.D., Chief Executive Officer of Tonix
Pharmaceuticals. “The designation underscores the importance of
addressing the unmet needs of fibromyalgia patients, who report
dissatisfaction with current treatment options. If approved by the
FDA, we expect Tonmya to become the first new pharmacotherapy for
fibromyalgia in over 15 years. The NDA being prepared supports
Tonmya’s potential position as a first line therapy for
fibromyalgia, indicated for long-term daily use at bedtime.”
The FDA’s Fast Track process is designed to
facilitate development and expedite the review of therapies
intended to treat serious conditions and address unmet medical
needs to potentially bring important new medicines to patients
sooner. Companies whose programs are granted Fast Track designation
are eligible for more frequent interactions with the FDA during
clinical development. Tonix plans to request Priority Review
designation, and if granted, FDA may accelerate the review of the
NDA. For more information on Fast Track designation, please visit
the FDA’s website
at www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
About Tonmya* (also known as TNX-102
SL)
Tonmya is a centrally acting, non-opioid,
analgesic investigational drug for bedtime use. 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 (all p≤0.001).
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 has announced the results of two positive
pre-NDA meetings and alignment with FDA on nonclinical, clinical
pharmacology, clinical and CMC features of the NDA submission.
About Fibromyalgia
Fibromyalgia is a common 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.
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. 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.
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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