Summary: Tonix Pharmaceuticals has announced that the FDA has accepted the New Drug Application (NDA) for TNX-102 SL, a non-opioid treatment for fibromyalgia. The NDA is supported by clinical trial data showing that TNX-102 SL improves pain relief and sleep quality, among other key endpoints. The drug has already received Fast Track designation from the FDA, and the company aims to address the unmet needs of the fibromyalgia community. Clinical trials demonstrated the drug’s safety and efficacy, with minimal side effects.
Key Takeaways:
- FDA Acceptance of NDA: The FDA accepted Tonix’s NDA for TNX-102 SL, a non-opioid treatment for fibromyalgia, based on clinical trial data.
- Clinical Trial Success: TNX-102 SL demonstrated significant improvements in pain relief, sleep quality, and other key symptoms in fibromyalgia patients.
- Fast Track Designation: The drug has received Fast Track status from the FDA to expedite the review process for this important treatment in the fibromyalgia community.
Tonix Pharmaceuticals Holding Corp announced that the US Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), a 5.6 mg, non-opioid, centrally-acting analgesic, for the management of fibromyalgia.
The drug has been shown to improve pain and sleep quality in fibromyalgia patients.
The FDA is expected to assign the NDA a Prescription Drug User Fee Act target action date in a Day 74 Letter. At that time, the FDA will also communicate to Tonix whether priority review has been granted. TNX-102 SL was granted Fast Track designation for fibromyalgia by the FDA in July 2024. Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.
“The FDA’s acceptance of our NDA represents another step forward as we pursue our goal of delivering the first member of a new class of medicines for the management of fibromyalgia, a condition affecting over 10 million adults in the US,” says Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, in a release. “The fibromyalgia community, comprised of patients and their families and support groups, has been waiting for a new drug for over 15 years. Analysis of insurance claims in the US, commissioned by Tonix, have shown that 18 months after diagnosis, fibromyalgia patients were more likely to be prescribed addictive opioids than all three of the FDA-approved drugs combined.”
Clinical Data Supporting NDA
The NDA is supported by data from two 14-week double-blind, randomized, placebo-controlled phase 3 clinical trials evaluating the safety and efficacy of TNX-102 SL as a bedtime treatment for fibromyalgia. The first phase 3 trial, RELIEF, of TNX-102 SL 5.6 mg in fibromyalgia, completed in December 2020, met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo.
In the confirmatory phase 3 RESILIENT study in fibromyalgia, completed in December 2023, TNX-102 SL again met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo. TNX-102 SL also demonstrated a broad spectrum of benefits with statistically significant improvement in all six pre-specified key secondary endpoints including those related to improved sleep quality, reduced fatigue, and improved patient global ratings and overall fibromyalgia symptoms and function.
The role of poor sleep in causing, perpetuating, or exacerbating fibromyalgia has been recognized for more than 50 years.
In the trials, TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and with no new safety signals observed. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study).
Excluding COVID-19, systemic adverse events in each of the two studies was lower than 4%. Tonix believes the submitted dossier contains the requisite safety and efficacy data from two adequate and well-controlled studies to support NDA approval.
“We look forward to working closely with the FDA throughout the NDA review period with the goal of bringing TNX-102 SL to the market to address the significant unmet needs of the fibromyalgia community as quickly as possible,” Lederman says in a release.
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