Palm Beach, FL – July 25, 2024 – The fibromyalgia treatment market has witnessed positive growth trends over the past few years. There is higher disease awareness due to growth in diagnosis rates and growing awareness and concern for this serious, debilitating condition. Moreover, rising healthcare expenditure and presence of favorable reimbursement policies are also contributing to the market expansion. New drugs in development having novel mechanisms of actions for this condition are further expected to bring more growth opportunities for this market in the near future.  The fibromyalgia treatment market involves prescription drugs and non-prescription remedies that provide relief from fibromyalgia, a chronic condition characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. This market includes drugs like antidepressants, pain relievers and anti-seizure medications as well as non-drug options like physical therapy, osteopathic manipulation, massage therapy and cognitive behavioral therapy which are aimed at managing fibromyalgia symptoms and improving overall health and quality of life for sufferers.  A report from Coherent Market Insights projected that the fibromyalgia treatment market is estimated to be valued at USD 3.07 Billion in 2024 and is expected to reach USD 3.86 Billion by 2031, exhibiting a compound annual growth rate (CAGR) of 3.3% from 2024 to 2031.  Active biotech, pharma companies in the markets this week include: Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), Pfizer Inc. (NYSE: PFE), Eli Lilly and Company (NYSE: LLY), AbbVie (NYSE: ABBV), Axsome Therapeutics, Inc. (NASDAQ: AXSM).

The Coherent Market Insights report said: “Market players are focusing on active research and development in order to introduce new products in the market and increase treatment options. Increasing approval and launch of novel fibromyalgia treatments are expected to drive the market growth over the forecast period.  North America has established itself as the dominant region in the global fibromyalgia treatment market and is estimated to hold 36.7% of the market share in 2024. The U.S., in particular, has a large patient base suffering from fibromyalgia due to growing awareness and clinical acceptance of the condition. Several major pharmaceutical companies have been operating in the country for decades and have well-established sales and distribution networks. This provides patients with easy access to approved drugs for fibromyalgia treatment. Furthermore, the reimbursement scenario for fibromyalgia drugs is favorable in the US due to fact that several government-funded health insurance plans primarily cover treatment costs. This encourages patients to seek and maintain medication-based fibromyalgia management. Leading generic manufacturers have also strengthened their presence by launching affordable generics of blockbuster brands, which are widely preferred due to their cost-effectiveness.”

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) Granted FDA Fast Track Designation for Tonmya for the Management of Fibromyalgia –

• Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need
• Fast Track designation for Tonmya recognizes fibromyalgia as a serious condition impacting more than 10 million U.S. adults
• NDA submission on track for second half 2024
• Tonmya has the potential to be the first new drug for treating fibromyalgia in more than 15 years

Tonix Pharmaceuticals Holding Corp. (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.   CONTINUED… Read this full press release and more news for Tonix Pharmaceuticals at:  https://ir.tonixpharma.com/news-events/press-releases

Other recent developments in the Fibromyalgia Drug industry of note include:

Eli Lilly and Company (NYSE: LLY)’s fibromyalgia drug, Cymbalta, is the first serotonin- norepinephrine reuptake inhibitor with proven efficacy for reducing pain in patients with fibromyalgia. The fibromyalgia indication represents the second FDA-approved use for Cymbalta for a pain disorder, demonstrating the medication’s analgesic effect.

Lilly established the efficacy of Cymbalta in two pivotal three-month clinical trials involving 874 patients with fibromyalgia. In both studies, Cymbalta reduced pain at study endpoint compared with placebo as measured by the Brief Pain Inventory (BPI) 24-hour average pain scale. The BPI is a scale that measures the severity of pain.

Significant improvement in pain for Cymbalta vs. placebo was observed in the first week of each study. Fifty-one percent and 55 percent of patients on Cymbalta had a 30 percent improvement on the BPI at endpoint (clinically meaningful relief is considered at least 30 percent pain reduction)

Pfizer Inc. (NYSE: PFE) originally reported Lyrica reduced pain of fibromyalgia in patients regardless of whether they experienced symptoms of anxiety or depression at the beginning of the study, according to a pooled analysis presented today at the American Academy of Neurology annual meeting. The analysis, which looked at data pooled from previous clinical trials, also showed that patients’ self-reported improvements were more closely associated with improvements in pain and sleep than with improvements in fatigue or symptoms of anxiety or depression.

“The data showed that Lyrica reduced fibromyalgia pain, and alleviating that pain was associated with patients’ overall feeling of well-being,” said Dr. Lesley Arnold, one of the study’s authors and associate professor in the department of psychiatry at the University of Cincinnati Medical Center. “Understandably, many patients with a chronic pain condition such as fibromyalgia also experience depression and anxiety, and importantly we found that Lyrica helped reduce pain in patients regardless of the presence of symptoms of these co-morbid conditions.”

SAVELLA, registered trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company (NYSE: ABBV), is an FDA-approved prescription medication for the management of fibromyalgia, a common, chronic condition that causes widespread pain.

This medication is used to treat pain caused by a condition called fibromyalgia that affects the muscles, tendons, ligaments, and supporting tissues. Milnacipran belongs to a class of drugs known as serotonin-norepinephrine reuptake inhibitors (SNRIs). It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain.

Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, AXS-14 (esreboxetine) is a novel, oral, investigational medicine. It is a highly selective and potent norepinephrine reuptake inhibitor.  Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine.  AXS-14 has met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and in a Phase 2 trial for the treatment of fibromyalgia.  AXS-14 is an investigational drug not approved by the FDA and its safety and effectiveness have not been established.

AXS-14 is currently being developed for the treatment of fibromyalgia. The product is in the preparation stages of an NDA.

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This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in Tonix Pharmaceuticals Holding Corp’s annual report on Form 10-K and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and neither the company nor FNM undertake any obligation to update such statements.

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