Summary: Tonix Pharmaceuticals announced that the FDA has set a PDUFA goal date of Aug 15, 2025, for the decision on marketing approval for TNX-102 SL, a non-opioid treatment for fibromyalgia. This decision follows positive results from two phase 3 clinical trials, where TNX-102 SL demonstrated significant reductions in daily pain, along with improvements in sleep quality, and was generally well-tolerated by patients. The drug has been granted Fast Track designation by the FDA, expediting the review process for this important treatment in the fibromyalgia community, which has seen limited new drug options for over 15 years.
Key Takeaways:
- PDUFA Goal Date Set for August 2025: The FDA has set a goal date for reviewing TNX-102 SL for fibromyalgia.
- Positive Phase 3 Trial Results: The drug showed significant improvements in daily pain relief in two phase 3 trials, along with improvements in sleep quality.
- Fast Track Designation: TNX-102 SL has received Fast Track status from the FDA, helping to expedite its review and address the unmet medical needs of fibromyalgia patients.
Tonix Pharmaceuticals Holding Corp announced that the US Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of Aug 15, 2025, for a decision on marketing approval for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia.
TNX-102 SL is a non-opioid, centrally-acting analgesic that has been shown to improve pain and sleep quality in fibromyalgia patients.
“We look forward to working closely with the FDA throughout the review period in advance of the August 15, 2025, PDUFA goal date,” says Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, in a release. “We believe that TNX-102 SL has the potential to be the first member of a new class of medicines for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the US. Data from our pivotal phase 3 trials support that TNX-102 SL can provide fibromyalgia patients with significant reduction in pain with favorable tolerability, helping to address the significant unmet need in this community.”
TNX-102 SL was previously granted FDA Fast Track designation for fibromyalgia 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.
Clinical Trial Data Supporting TNX-102 SL for Fibromyalgia
The accepted New Drug Application 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 (p=0.010).
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 (p =0.00005). 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 both 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, rates of systemic adverse events in each of the two studies were all below 4%. Tonix believes the submitted dossier contains the requisite safety and efficacy data from two adequate and well-controlled studies to support NDA approval.
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