• Non-opioid drug candidate from Tonix lowered pain and also improved sleep and fatigue
• Latest Phase 3 trial achieved primary endpoint (p=0.00005)
• Potential for FDA Approval in 2025

CHATHAM, NJ / ACCESSWIRE / February 15, 2024 / People who are suffering from fibromyalgia pain but don't want to risk addiction to an opioid are closer to a new option for treatment.

Tonix Pharmaceuticals (NASDAQ:TNXP) reported positive Phase 3 study results for its non-opioid painkiller in late December. The drug lowered the characteristic widespread pain in fibromyalgia reported by study volunteers, a sign it could potentially be the first in a new class of painkillers to be approved for use in fibromyalgia.

The experimental medicine also improved sleep and fatigue in fibromyalgia, suggesting that it may reduce the use of multiple drugs - called polypharmacy - which is common in fibromyalgia.

With the current FDA-approved drugs, fibromyalgia patients face a choice: take Lyrica^® and have less energy, or take Cymbala^® or Savella^® and have worse sleep. Tonix's new drug, Tonmya™, improved pain, sleep and fatigue in fibromyalgia patients.

Tonix says it will file for approval from the U.S. Food and Drug Administration in the second half of this year.

"When Tonmya is approved, as we expect, it will offer a new option for patients who need pain relief but who do not want to take an opioid and can't tolerate any of the three approved drugs," Tonix Chief Executive Officer Seth Lederman, MD said. "For Tonmya, the most common systemic side effects - headache and somnolence - were reported in about 3% of patients. No changes to weight or blood pressure were observed, which are issues with other fibromyalgia drugs. Tonmya is a sublingual tablet, and the most common local administration side effect was tongue numbness, which was transient and self-limited. Ultimately, we believe Tonmya has the potential to be a first-line treatment for newly diagnosed patients."

Tonix said the researchers who conducted the Phase 3 study plan to present the data at upcoming scientific meetings and hope to publish their results in a peer-reviewed journal later this year.

About 10 million Americans suffer from fibromyalgia, and the majority are prescribed medicine for the characteristic widespread pain. The three approved products to treat that symptom in fibromyalgia are Lyrica, Cymbalta and Savella. Many patients report they are hard to tolerate. As a result, many take opioids because they provide relief or because they have become addicted or dependent on them. The crackdown on opiate prescriptions has reduced the use of prescription opiates, but it is feared that the crackdown has pushed many patients out of the prescription drug channels and towards illegal drugs like heroin or street fentanyl.

To avoid addiction, many doctors, patients and health authorities have sought an alternative that provides relief from fibromyalgia pain without creating any dependence on use. Previous and current non-opioid approaches to managing pain in fibromyalgia have carried tolerability issues.

Tonix's Tonmya, formerly codenamed TNX-102 SL, belongs to a class of medicines that targets molecular mechanisms involved in sleep quality. Researchers have recognized for many years that fibromyalgia pain and poor sleep are correlated. Some research suggests that poor sleep has the potential to cause fibromyalgia pain. Many experts believe poor sleep may perpetuate or exacerbate fibromyalgia pain. Tonix reports that this is the first program that pursued a drug to improve sleep quality in fibromyalgia with the goal of improving fibromyalgia pain.

Tonmya blocks the action of four distinct neurotransmitter receptors, each of which in the brain plays a role in alertness, awareness, vigilance or even alarm. During the time fibromyalgia patients want to sleep, these receptors can disrupt sleep quality when allowed to function unchecked.

Tonmya was designed to deliver the active ingredient into the brain during sleep and reduce its presence during wakefulness, and the drug works by blocking or diminishing the alertness-promoting signals in the brain.

It is known that the brain is responsible for the sensation of pain. How good sleep quality resets the brain's perception is not fully known.

New Jersey-based Tonix studied Tonmya in three late-stage, or Phase 3, trials that enrolled more than 1,400 subjects with fibromyalgia. In the latest fibromyalgia Phase 3 study, Tonmya showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. The company also studied TNX-102 SL in three late-stage trials that enrolled more than 1,200 subjects with post-traumatic stress disorder (or PTSD), which has a different sleep disturbance.

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

Featured photo by sutadimages on Shutterstock.

Disclosures:

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. to provide 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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