A poster presentation highlighted results from a phase 3 study demonstrating statistically significant improvement in the primary endpoint of fibromyalgia pain and in all six key secondary endpoints, including sleep quality.
Summary: Tonix Pharmaceuticals presented new data at the American College of Rheumatology’s 2024 meeting, demonstrating that its drug candidate TNX-102 SL significantly reduces pain and improves sleep quality in fibromyalgia patients. In the phase 3 RESILIENT study, the drug met its primary endpoint and showed improvements across all secondary endpoints, including sleep and fatigue. Tonix has submitted a new drug application to the FDA, with a potential decision expected in 2025.
Key Takeaways:
- Significant Pain and Sleep Improvement: TNX-102 SL significantly reduced pain and improved sleep quality, meeting the primary and all secondary endpoints in the phase 3 RESILIENT study.
- Potential New Treatment for Fibromyalgia: If approved, TNX-102 SL could become the first new drug treatment option for fibromyalgia patients in 15 years, targeting non-restorative sleep.
- FDA Review Underway: Tonix has submitted an NDA to the FDA, with a potential decision expected in 2025 based on the Prescription Drug User Fee Act timeline.
Tonix Pharmaceuticals presented data at the American College of Rheumatology’s 2024 meeting, showing that TNX-102 SL—a potential non-opioid analgesic targeting non-restorative sleep—significantly improves pain and sleep quality in fibromyalgia patients.
In the phase 3 RESILIENT study, TNX-102 SL met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo in participants with fibromyalgia. In the study, TNX-102 SL 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.
TNX-102 SL was generally well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed.
“Fibromyalgia is the prototypic nociplastic syndrome and one of the chronic overlapping pain conditions,” says Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, in a release. “TNX-102 SL, designed as a bedtime treatment to target non-restorative sleep, has shown a statistically significant improvement in pain in two phase 3 studies. We believe TNX-102 SL has the potential to be the first new drug treatment option for fibromyalgia patients in 15 years.”
Tonix submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) in October for TNX-102 SL for the management of fibromyalgia. The FDA typically has a 60-day filing review period to determine whether the submitted NDA is complete and accepted for review. If the FDA accepts the NDA for review, the company expects a 2025 date for an FDA decision on approval, based on the Prescription Drug User Fee Act.
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I am excited about this new drug for fibromyalgia. I have suffered with it for years.
Thank you so much for everything.
I could only continue with previous prayers to find relieve. I’m soooo tired all the time. Now my teeth are breaking and need to be removed from the gums. I have no front teeth and have you looked at prices for implants? Up to $40,000.00 for ONE( either upper or lower)
I started feeling the effects of fibromyalgia right after my mother died in 2012 and have suffered since with increased pain since then. My mother also had severe arthritis, spinal stenosis, fibromyalgia, PMR, border line Lupus and all the complications that go with this from neurogenic bladder, urinary infections, sleep disorders, etc etc. I took care of her for years and watched as she slowly declined and her quality of life diminished quickly. Her pain was never managed appropriately and no one really ever addressed the depression and anxiety that comes with it. My mom worked at a hospital for 30 plus years, but yet I had to watch as she would literally cry to her doctors about how bad the pain was and leave there feeling like they looked at her like someone just seeking drugs. It was so sad to watch a beautiful, hard working, Christian lady who never even drank alcohol have to go through this. I refuse to go through this myself or be treated in that manner. I will be an advocate for my self and anyone else I run across who needs one. When I come across a doctor who treats me in such a manner, I kindly remind him who I am and let him know I am not one of those abusing drugs, but seeking help….I remind him that even the addicts out there involved in abusing drugs are people too and most have a story no one knows about! I remind him of his duty to up hold his sacred duty to heal and not hurt 😞 and that includes anyone who crosses his path in the field of medicine. I remind him to see the person behind the disease! I also thank him for his service and remind myself how important I am and to never go back there again. As a nurse myself, do you know how many times I have heard medical staff say about patients…”oh she’s just here seeking drugs” or read doctors notes that say the same!! Sorry, but it makes me sick!! Thank God for doctors, scientists and all the research teams out there trying to find ways to actually help people!!