Full Press Release Details
TONIX PHARMACEUTICALS HOLDING CORP. 8-K
Tonix Pharmaceuticals Announces Key Findings from
Initial Phase of EVERSANA Market Opportunity Analysis for Tonmya for the Management of Fibromyalgia
Tonmya is a potential new first-line, centrally
acting non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials
Primary physician research found high level of interest
in Tonmya as a potential new treatment option for fibromyalgia
Significant dissatisfaction reported with drugs
currently approved by FDA for the treatment of fibromyalgia
Analysis of claims data revealed that addictive
opioids are prescribed more frequently than currently approved drugs following fibromyalgia diagnosis
New Drug Application (NDA) submission to the FDA
on track for the second half of 2024
CHATHAM, N.J., May 21, 2024 (GLOBE NEWSWIRE) -- 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
"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
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:
Key findings from primary physician research4:
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 Tonix
3Note: 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
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