The news was shared at at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain in Amsterdam.
The company presented data demonstrating that TNX-102 SL significantly reduced pain and improved sleep quality in fibromyalgia patients, positioning it as a potential breakthrough in treating this debilitating condition.
Fibromyalgia, recognized as a nociplastic pain syndrome, involves altered pain perception originating in the brain. This condition affects millions worldwide and is characterized by widespread pain, fatigue, and disrupted sleep, significantly impacting patients' quality of life. Tonix’s TNX-102 SL, administered at bedtime, was developed to address non-restorative sleep, a key factor in the persistence of fibromyalgia symptoms.
The phase 3 Resilient study results showed that TNX-102 SL met its primary endpoint, achieving a statistically significant reduction in daily pain compared to a placebo. Specifically, the drug showed a p-value of 0.00005, underscoring its efficacy. Additionally, the study demonstrated significant improvements across all six key secondary endpoints, which included measures of sleep quality, fatigue reduction, and overall fibromyalgia symptom management.
Dr Seth Lederman, CEO of Tonix Pharmaceuticals, explained the importance of these findings, he said: “Approximately 50 years ago, the central role of non-restorative sleep in the pathogenesis and persistence of fibromyalgia was recognized by Dr Harvey Moldofsky. TNX-102 SL was designed as a bedtime treatment to target non-restorative sleep and improve sleep quality.
Evidence of activity and tolerability in fibromyalgia
“The statistically significant results of TNX-102 SL in two positive phase 3 studies provide evidence of the activity and tolerability of TNX-102 SL in fibromyalgia and also support the critical role of sleep quality in the pathogenesis, persistence, and exacerbations of fibromyalgia.”
In addition to the primary findings, a post hoc analysis highlighted a strong correlation between pain reduction and improved sleep quality by week 14 of the study. This supports the hypothesis that enhancing sleep quality could lead to broader syndromal improvement in fibromyalgia patients. Importantly, TNX-102 SL was well tolerated by participants, with an adverse event profile consistent with prior studies and no new safety concerns.
Dr Greg Sullivan, chief medical officer at Tonix said: “Today, fibromyalgia is recognized as the prototypic ‘nociplastic syndrome.’ Understanding nociplastic syndromes is crucial for developing effective treatment strategies for chronic overlapping pain conditions or COPCs.
“Traditional analgesics like NSAIDs or opioids often prove ineffective, if not deleterious, in these conditions. In contrast, TNX-102 SL provided broad-spectrum symptom relief in the Resilient study. We believe TNX-102 SL has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”
The US Food and Drug Administration (FDA) has granted TNX-102 SL Fast Track designation for the management of fibromyalgia, further highlighting its potential impact on patient care. Tonix Pharmaceuticals remains on track to submit a New Drug Application (NDA) for TNX-102 SL in the second half of 2024, paving the way for what could be a transformative treatment option for fibromyalgia patients.
As the medical community continues to seek more effective therapies for fibromyalgia and other nociplastic pain syndromes, TNX-102 SL's promising results offer hope for millions of sufferers worldwide. With the possibility of becoming the first new fibromyalgia treatment in over a decade, Tonix Pharmaceuticals is poised to make a significant contribution to the field of pain management.
