New Hope For Fibromyalgia Patients: Tonix Details Results Of Second Successful Phase 3 Trial And Plans To File For FDA Approval

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Tonix Pharmaceuticals (NASDAQ:TNXP) has a potential new treatment for fibromyalgia with TNX-102 SL, hitting the primary endpoint of daily pain reduction with a p-value of 0.00005. TNX-102 SL targets poor sleep quality rather than sleep quantity, improving the daily lives of fibromyalgia patients. The company plans to file an NDA for FDA approval in the second half of 2024.
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The recent announcement from Tonix Pharmaceuticals regarding their fibromyalgia candidate, TNX-102 SL, is a significant development within the pharmaceutical industry. The candidate's success in meeting the primary endpoint of daily pain reduction with a highly significant p-value of 0.00005 suggests a robust clinical finding. Moreover, the drug's focus on improving sleep quality, rather than merely increasing sleep duration, addresses a core issue in fibromyalgia management, potentially offering a differentiated mechanism of action compared to existing FDA-approved treatments like Cymbalta, Lyrica and Savella.

From a medical research perspective, the dual benefits of pain reduction and sleep quality improvement could position TNX-102 SL as a promising first-line therapy. The additional reported improvements in fatigue, symptoms, function and sexual function in women, without impacting weight or blood pressure, could further distinguish TNX-102 SL from current treatments, which often come with burdensome side effects. This favorable tolerability profile is crucial for patient adherence, especially considering fibromyalgia's chronic nature and the need for long-term management.

The financial implications for Tonix Pharmaceuticals and the broader market are considerable, given the reported efficacy of TNX-102 SL and the unmet needs in the fibromyalgia treatment landscape. The reference to past peak sales of approximately $10 billion for the combined annual sales of Cymbalta and Lyrica underscores the market potential for TNX-102 SL, especially since these drugs are now off-patent. A new, effective treatment could capture a significant share of this market.

Investors should note the planned submission of a New Drug Application (NDA) to the FDA under the 505(b)(2) pathway in the second half of 2024, which may offer a streamlined approval process. The company's expressed confidence in being on track to supply the U.S. market upon FDA approval suggests a clear commercial strategy. However, until approval is granted and commercialization begins, there are risks inherent in the investment. These include potential regulatory hurdles, manufacturing and distribution challenges and market acceptance of the new therapy.

Understanding the competitive landscape is essential for evaluating TNX-102 SL's potential market penetration. The dissatisfaction with current fibromyalgia medications, as suggested by frequent patient switching and the use of off-label drugs, indicates a substantial opportunity for a new entrant like TNX-102 SL. The drug's novel approach to treating fibromyalgia by focusing on sleep quality could meet a significant unmet need and drive physician interest and patient demand.

Additionally, the improvement of sexual function in women as a secondary benefit could be a compelling differentiator in the market, considering the importance of holistic treatment outcomes for patients. The drug's profile may also reduce the reliance on opioids, which is a critical public health objective. Market acceptance will depend on the drug's efficacy, safety profile, pricing strategy and the company's ability to effectively communicate these benefits to healthcare professionals and patients.

Fibromyalgia candidate TNX-102 SL hits primary endpoint of daily pain reduction (p=0.00005)
Combination of broad-spectrum relief and favorable tolerability seen as distinguishing, competitive features
Company plans to file an NDA for FDA approval in 2H 2024

CHATHAM, NJ / ACCESSWIRE / February 1, 2024 / Tonix Pharmaceuticals (NASDAQ:TNXP) appears to have a potential new weapon against fibromyalgia for the 6-12 million adults in America suffering from its debilitating effects.

It has to do with sleep quality, not sleep quantity.

Tonix's candidate drug TNX-102 SL*, which just completed its second successful Phase 3 clinical trial, targets poor sleep quality - not sleep quantity - as the key mechanism to improve the daily lives of people afflicted with fibromyalgia.

Traditional sleeping pills, which are called sedatives or hypnotics, speed the onset of sleep, and increase the amount of time spent asleep. But these barbiturate, "benzo" or "non-benzo" type drugs often impair the quality of sleep. The quality of sleep is usually measured by how someone feels the next day. Fibromyalgia patients suffer from poor sleep quality. A core pathology of the fibromyalgia syndrome prevents affected patients from being able to get restorative sleep.

Tonix believes TNX-102 SL's ability to facilitate restorative sleep is what drove the successful efficacy and tolerability outcomes in two successful Phase 3 trials in the management of fibromyalgia. TNX-102 SL treatment is based on the hypothesis that poor sleep is an obstacle to recovery and that if the obstacle of poor sleep quality can be addressed, then fibromyalgia patients have a better chance at recovery.

A filing for marketing approval with the FDA is scheduled for the second half of this year, the company said.

"'I hurt all over and I can't sleep,' are the two most frequent complaints of fibromyalgia patients", says Seth Lederman, MD, the CEO of Tonix, who years ago cared for fibromyalgia patients at the rheumatology clinic at Columbia Medical School. He added, "Sometimes fibromyalgia patients will volunteer that a good night's sleep can bring relief."

The company's latest Phase 3 trial in fibromyalgia (457 patients randomized 1:1 drug to placebo) showed TNX-102 SL successfully improved sleep quality over placebo with a highly significant p-value of 0.0000001 in the PROMIS sleep scale and achieved its primary endpoint of daily pain reduction with a highly statistically significant p-value of 0.00005.

Improved Sexual Function in Women

"We believe the overall success of the trial and the strength of the effect on the primary endpoint are due to the kind of sleep fibromyalgia patients experience when they are taking TNX-102 SL therapy," says Dr. Lederman. "Our studies have shown TNX-102 SL increases sleep quality in fibromyalgia. Beyond sleep and pain, TNX-102 SL also improves other key characteristics of the fibromyalgia syndrome. For example, TNX-102 SL treated patients had less fatigue, fewer symptoms and better function. So far, TNX-102 SL has not shown any effects on weight or blood pressure in our trials. In addition, in the latest study, TNX-102 SL therapy improved sexual function in women as measured by the CSQ-14 score."

TNX-102 SL's ability to reduce pain, coupled with its tolerability and favorable side effects profile, may give hope to fibromyalgia patients. If approved by the FDA, TNX-102 SL would be the first new drug approved for fibromyalgia in more than a dozen years. It would also be the first member of a new class of drugs for fibromyalgia, since it has a totally new mechanism of action, relative to the three drugs that have been approved.

Three drugs have been FDA-approved for fibromyalgia, but their long-term use is often problematic due to side effects. Widespread dissatisfaction with the current medicines is reported. The three currently FDA-approved medicines for fibromyalgia are Cymbalta®, Lyric®, and Savella®. They are generally thought to be effective in reducing pain. None is associated with improvements in both sleep and fatigue, like TNX-102 SL. Some of the treatment-limiting side effects of these medicines include weight gain, blood pressure, and sexual dysfunction.

Despite these shortcomings, Cymbalta and Lyrica, both now off patent, enjoyed combined annual peak sales of approximately $10 billion.

The unmet treatment needs in fibromyalgia lead many patients to switch frequently between approved drugs, and then to off-label drugs, home remedies, and addictive opioids.

"Fibromyalgia is a chronic condition that often persists for decades. It can be treated, but there is no cure yet", Dr. Lederman adds. "Adherence to the prescribed medicines is critical to achieving the best outcomes. Therefore, tolerability is important. We think TNX-102 SL has the potential to be a first-line medicine suitable for long-term use in managing fibromyalgia."

The recently reported RESILIENT Phase 3 trial and the earlier Phase 3 RELIEF trial completed in 2020 position the company to submit a New Drug Application (NDA) to the FDA under the 505(b)(2) regulatory approval pathway, which it plans to do in the second half of 2024. The company said it is on track to supply the U.S. market upon FDA approval.

Tonix has several other category-leading drug candidates in development. Among them are TNX-2900 for Prader-Willi syndrome, TNX-1500 for organ transplant rejection and autoimmune diseases, and TNX-1300, an antidote to cocaine intoxication.

CLICK HERE for more information on Tonix Pharmaceuticals

*Tonix's product development candidates, including TNX-102 SL, are investigational new drugs or biologics and have not been approved for any indication.

Featured photo by National Cancer Institute on Unsplash.

Important notice, please read: Certain statements in this document 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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; 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, 2022, as filed with the Securities and Exchange Commission (the "SEC") in March 2023, and periodic reports filed with the SEC on or after the date thereof. All 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. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.


Tonix Pharmaceuticals Holding Corp.
Jessica Morris

SOURCE: Tonix Pharmaceuticals

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TNX-102 SL hit the primary endpoint of daily pain reduction with a p-value of 0.00005.

TNX-102 SL targets poor sleep quality, not sleep quantity, to improve the daily lives of fibromyalgia patients.

Tonix Pharmaceuticals plans to file an NDA for FDA approval in the second half of 2024.

6-12 million adults in America suffer from fibromyalgia.

TNX-102 SL has shown no effects on weight or blood pressure in trials and improved sexual function in women.
Tonix Pharmaceuticals Holding Corp


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About TNXP

tonix is developing innovative pharmaceutical products to address major public health challenges. in addition to tonmya for ptsd, tonix is developing tnx-601 (tianeptine oxalate), a clinical candidate at pre-ind (investigational new drug) application stage, designed as a daytime treatment for ptsd and tnx-801, a live synthetic version of horsepox virus, at the pre-ind application stage, to be developed as a potential smallpox-preventing vaccine. further information about tonix can be found at