Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or
the Company), a fully-integrated biopharmaceutical company with
marketed products and a pipeline of development candidates,
announced today that EVERSANA® Life Science Services, LLC, a
leading provider of commercialization services to the global life
sciences industry, completed the initial phase of an assessment of
the U.S market opportunity for TonmyaTM (also known as TNX-102 SL,
cyclobenzaprine HCl sublingual tablets), a potential new first line
therapy for the management of fibromyalgia. Tonix previously
announced that EVERSANA was selected to support the launch strategy
and commercial planning of Tonmya. Specifically, EVERSANA is
working with Tonix to assess the fibromyalgia landscape and help
plan an efficient go-to-market (GTM) strategy.
“The primary research and analysis conducted by
EVERSANA provides valuable insights and informs the vision for the
commercialization of Tonmya,” said Seth Lederman, M.D., Chief
Executive Officer of Tonix Pharmaceuticals. “We are excited to
refine our business strategy for the anticipated launch of Tonmya
in 2025. It has been approximately fifteen years since patients
suffering with fibromyalgia have been provided a new therapeutic
option. The market research conducted by EVERSANA with physicians
indicates a continued high unmet need, with the need ranked >
4.0 on a 5-point scale.”
Dr. Lederman continued, “We were surprised to
learn that opioids dominate the fibromyalgia prescription market,
despite the well-known risks of dependency. Opioids are prescribed
to more patients following fibromyalgia diagnosis than all the
FDA-approved fibromyalgia drugs combined. If approved, we believe
that Tonmya can provide a non-opioid, centrally-acting solution for
fibromyalgia patients. This is corroborated by EVERSANA’s primary
market research in which physicians indicated median interest of
4.0 on a 5-point scale and intended use of Tomya in 40% of their
fibromyalgia patients, upon approval.1 We look forward to
submitting the NDA for Tonmya in the second half of this year and
expect an FDA decision on approval in 2025.”
EVERSANA’s analysis of the market size was based
on medical claims databases and epidemiological studies on
prevalence and diagnosis2. Primary research with physicians was
conducted to test the potential adoption of Tonmya based on its
activity and tolerability.
Key findings from claims data
analyses2:
- ~2.7 million adults in the U.S.
currently diagnosed and treated for fibromyalgia.
- ~90 percent of patients diagnosed
with fibromyalgia are female.
- Percentage of fibromyalgia patients
who were prescribed certain drugs3:
- FDA-approved fibromyalgia drug prescriptions:
- Duloxetine (generic Cymbalta®): 23%, pregabalin (generic
Lyrica®): 13%, and Savella® (milnacipran): 1%
- Off-label drug prescriptions:
- Gabapentin: 26%, hydroxycodone: 20%, cyclobenzaprine: 18%,
oxycodone: 19%, tramadol: 13%, meloxicam: 12%, and amitriptyline:
6%
- Off-label opioids prescriptions:
- Hydroxycodone: 20%, oxycodone: 19%, and tramadol: 13%
- Targeted prescriber strategy for
launch.
- High prescribers are
rheumatologists, pain medicine specialists, primary care
physicians, neurologists, and psychiatrists.
- ~50 percent of diagnosed
fibromyalgia patients are covered by Medicare.
- Medicare population stands to
benefit from a decrease in out-of-pocket prescription drug
liability to $2,000 per year when the changes from the Inflation
Reduction Act are enacted in 2025.
Key findings from primary physician
research4:
- High level of dissatisfaction with
currently prescribed drugs.
- Physicians interviewed estimate
that 85% of their patients fail first-line therapy due to efficacy
and tolerability issues and 79% of their patients are on multiple
therapies.
- Prescribers indicate high unmet
need in fibromyalgia, ranked >4.0 on a 5-point scale.
- High level of interest in Tonmya
from physicians interviewed as a potential new treatment option
based on favorable activity and tolerability profile observed in
Tonmya fibromyalgia clinical studies.
- Median interest in Tonmya of 4 on a
5-point scale.
- Physicians indicated intended use
of Tonmya in 40% of their fibromyalgia patients.1
Tonmya is a centrally acting, non-opioid
medication. As previously announced, Tonix’s second statistically
significant Phase 3 study, RESILIENT, 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 (p=0.001 or better)
were also seen in all key secondary endpoints related to improving
sleep quality, reducing fatigue, and improving overall fibromyalgia
symptoms and function.
Tonix plans to submit an NDA to the U.S. Food
and Drug Administration (FDA) in the second half of 2024 for Tonmya
for the management of fibromyalgia and has scheduled a Type B
pre-NDA meeting with FDA for the second quarter of 2024.
1 40% was the median preference share among
physicians interviewed, assuming no market access barriers.2
EVERSANA analysis of claims database, May 2024; commissioned by
Tonix3Note: the total number of patients is greater than 100%
because of switching between medications and polypharmacy.4
EVERSANA primary physician research, May 2024; commissioned by
Tonix
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, 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.
*Tonmya™ 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.
About EVERSANA®
EVERSANA® is a leading independent provider of
global services to the life sciences industry. The company’s
integrated solutions are rooted in the patient experience and span
all stages of the product life cycle to deliver long-term,
sustainable value for patients, prescribers, channel partners and
payers. The company serves more than 650 organizations, including
innovative start-ups and established pharmaceutical companies, to
advance life sciences solutions for a healthier world. To learn
more about EVERSANA, visit eversana.com or connect through
LinkedIn and X.
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 positive 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 with 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.
*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 commercialize 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
Matt BraunEVERSANAMatt.braun@eversana.com
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