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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