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New Drug Study Shows Improving Sleep Quality Can Relieve Fibromyalgia Pain

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Tonix Pharmaceuticals (TNXP) has developed a bedtime drug targeting fibromyalgia's poor sleep quality, showing promising results in reducing widespread pain. The drug, Tonmya, demonstrated significant pain improvement in a phase 3 study, with a potential FDA approval in 2025.
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  • Tonix Pharmaceuticals (TNXP) has reported positive study results for its sleep-quality targeted therapy, Tonmya, in late December.
  • The drug showed a significant reduction in widespread pain in fibromyalgia patients, indicating a potential breakthrough in treatment.
  • In a phase 3 study, Tonmya demonstrated a highly statistically significant improvement in daily pain relative to placebo, with a p-value of 0.00005.
  • The results also highlighted favorable tolerability with no unexpected side effects, positioning Tonmya as a promising candidate for FDA approval in 2025.
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The recent phase 3 study results from Tonix Pharmaceuticals concerning the drug Tonmya® are promising for the fibromyalgia patient community. The highly statistically significant p-value of 0.00005 indicates a strong likelihood that the observed pain reduction is not due to chance. This is particularly notable as fibromyalgia treatments often have a dual focus on pain relief and sleep quality improvement, addressing the core symptom of non-restorative sleep that exacerbates pain perception.

From a business perspective, the potential FDA approval of Tonmya® in 2025 could position Tonix as a leader in the fibromyalgia treatment market. The lack of unexpected side effects further strengthens the drug's profile, potentially leading to a competitive advantage over existing treatments, which often come with significant side effects. If approved, this could lead to a substantial increase in market share and revenue for Tonix Pharmaceuticals.

As a novel therapeutic agent, Tonmya® represents a significant advancement in fibromyalgia care. Current treatments often involve off-label use of drugs approved for other conditions, such as antidepressants or anticonvulsants, which do not specifically target fibromyalgia's unique pathology. The focus on improving sleep quality as a mechanism for pain reduction is a differentiated approach that aligns with the latest understanding of fibromyalgia's pathophysiology.

Long-term implications for stakeholders include the potential for reduced healthcare costs associated with better-managed fibromyalgia symptoms and a decrease in the use of less effective and potentially more harmful treatments. However, the long-term efficacy and safety of Tonmya® will need to be monitored post-approval to ensure sustained benefits for patients.

The positive outcomes of the Tonmya® phase 3 study could have a ripple effect on the broader market for fibromyalgia treatments. The drug's success may encourage investment in therapies that target sleep quality to manage chronic pain conditions, potentially expanding the market with new drug classes. Additionally, the focus on fibromyalgia, a condition with a high unmet medical need, may attract interest from investors looking for opportunities in niche but growing healthcare segments.

It is important to consider the patient population size and the pricing strategy Tonix may adopt, as these will influence the market dynamics and the drug's accessibility. The impact on Tonix's stock will depend on the market's perception of the drug's potential for success and its ability to secure FDA approval without delays.

Bedtime drug being developed by Tonix relieved pain by targeting fibromyalgia's characteristic "non-restorative sleep": Potential for FDA Approval in 2025

CHATHAM, NJ / ACCESSWIRE / February 26, 2024 / People who are suffering from fibromyalgia pain are closer to a new option for treatment that targets their characteristically poor sleep quality.

Tonix Pharmaceuticals (TNXP) reported positive study results for its sleep-quality targeted therapy in late December. The drug reduced widespread pain in fibromyalgia reported by study volunteers, a sign it could be the first in a new class of painkiller to be approved for use in fibromyalgia.

In the latest fibromyalgia phase 3 study, Tonix's product candidate Tonmya®* improved fibromyalgia pain with a highly statistically significant p-value of 0.00005 on the primary endpoint which was the improvement in daily pain relative to placebo. The results also showed favorable tolerability with no unexpected side effects.

About 10 million Americans suffer from fibromyalgia and the majority are prescribed a medicine for the characteristic widespread pain.

It is known that the brain creates the feeling of pain. Fibromyalgia results when the brain becomes overly sensitive. The fibromyalgia brain sounds the pain alarm in response to sensory experiences that most healthy people ignore. Brain imaging studies have revealed that the fibromyalgia pathology activates the same parts of the brain that pain normally activates in healthy people. Consequently, the pain that fibromyalgia patients experience is real to them. It is unknown how fibromyalgia turns up the volume on brain sensitivity. It is also unknown how good sleep is able to reset the fibromyalgia brain's over-sensitive perception.

The experimental medicine targets the characteristic sleep disturbance of fibromyalgia, called "non-restorative sleep." People with fibromyalgia wake up feeling unrefreshed because their sleep fails to provide the restorative properties that healthy people enjoy. While targeting sleep is the novel mechanism of the new drug, it also provides a direct benefit because sleep disturbance is one of the core symptoms of fibromyalgia. In the study, Tonmya improved sleep quality relative to placebo by both the PROMIS sleep disturbance scale p = 0.0000001 and a daily sleep diary p = 0.0007.

The role of poor sleep in causing, perpetuating or exacerbating fibromyalgia has been recognized for more than 50 years. In the 1970's, Professor Harvey Moldofsky at the University of Toronto deprived undergraduates of deep sleep and found that most of them developed symptoms of fibromyalgia.

Developing drugs to target fibromyalgia's characteristic sleep problem has been challenging. Daily bedtime Ambien® (zolpidem) was studied and did not improve fibromyalgia. Intriguing results were achieved by treating fibromyalgia patients with the sleep drug Xyrem® (sodium oxybate). That drug induces a profoundly deep sleep and is approved for narcolepsy. It is hard to rouse people after taking Xyrem. While the results with Xyrem were scientifically interesting, an advisory committee to the U.S. Food and Drug Administration (FDA) voted against approval for fibromyalgia and the sponsor, Jazz Pharmaceuticals decided not to pursue approval. Because of the risk of diversion for date rape, Xyrem is burdened by a complex risk evaluation and mitigation strategy (REMS) program.

This history with Ambien shows that the type of sleep drug and its particular effect on sleep are important in determining whether it will be therapeutic for fibromyalgia. Tonix's new drug candidate Tonmya™ improves sleep quality by blocking four receptors in the brain, each of which plays roles in disturbing sleep.

The normal function of these four receptors is to increase alertness, vigilance or wakefulness or to sound the alarm to wake up. Consequently, when they fire during sleep, they can play pathological roles in fibromyalgia. During the time fibromyalgia patients want to sleep, these receptors can disrupt sleep quality. By blocking these receptors during sleep, Tonmya improves the quality of sleep and removes an obstacle to recovery.

Tonix's drug, also known as TNX-102 SL, belongs to a new class of medicines for fibromyalgia. Tonmya's active ingredient has a chemical structure with three rings, so it is called a "tricyclic." The Tonix drug is a sublingual tablet to be taken at bedtime, designed to deliver the active ingredient into the brain during sleep and reduce its presence during wakefulness. This is the first program pursuing a drug to improve sleep quality in fibromyalgia since 2009 that is headed to the FDA for a decision on approval. Tonix says it intends to file for approval by submitting a New Drug Application (NDA) with the FDA in the second half of this year. The company expects a decision from the FDA in 2025.

"If and when Tonmya is approved, it will offer a new first line treatment option for fibromyalgia patients," Tonix Chief Executive Officer Seth Lederman, M.D., said. "Ultimately, we believe Tonmya will also be an option for patients who need pain relief but can't tolerate or don't respond to the currently marketed drugs for fibromyalgia. Because Tonmya targets sleep quality, we believe it's a major step forward in both the treatment of fibromyalgia and in understanding the roles of non-restorative sleep in causing or exacerbating fibromyalgia."

With the current FDA-approved drugs, fibromyalgia patients face tough choices: take Cymbala® (duloxetine) from Eli Lilly or Savella® (milnacipran) from Abbvie, Inc. and risk insomnia or take Lyrica® (pregabalin) from Pfizer, Inc. and risk increased fatigue. Tonmya demonstrated improved pain, sleep and fatigue in fibromyalgia patients in its confirmatory phase 3 study.

New Jersey-based Tonix studied Tonmya in three late-stage, or phase 3, trials that enrolled more than 1,400 subjects with fibromyalgia. Tonix also studied TNX-102 SL in three phase 3, trials that enrolled more than 1,200 subjects with posttraumatic stress disorder (PTSD) which has a different sleep disturbance.

Axsome plans to file a new drug application this quarter for esreboxetine for the management of fibromyalgia. Esreboxetine has a mechanism similar to Cymbalta and Savella but is more specific for norepinephrine reuptake.

*Tomya is conditionally accepted by the U.S. Food and Drug Administration (FDA0 as the tradename for TN-102 SL for the management of fibromyalgia. Tonmya is an investigational new medicine and has not been accepted for any indication.

Featured photo by Jonathan Borba on Unsplash.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-benzinga-24023/

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.

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Tonix Pharmaceuticals Holding Corp.
Jessica Morris (corporate)
investor.relations@tonixpharma.com

SOURCE: Tonix Pharmaceuticals



View the original press release on accesswire.com

Tonix Pharmaceuticals' drug targeting fibromyalgia, Tonmya, has the potential for FDA approval in 2025.

In the phase 3 study, Tonmya showed a highly statistically significant improvement in daily pain relative to placebo, with a p-value of 0.00005.

The study results indicated favorable tolerability with no unexpected side effects reported by the study volunteers.

Tonix Pharmaceuticals' drug targets fibromyalgia's poor sleep quality to alleviate widespread pain in patients.
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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 www.tonixpharma.com.