Thelansis

  Tonix Pharmaceuticals Holding Corp. has announced the submission of a NDA to the U.S. Food and Drug Administration (FDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, centrally-acting analgesic. This drug has shown statistically significant reduction in chronic, widespread pain associated with fibromyalgia in two Phase 3 studies and was generally well tolerated. The FDA granted TNX-102 SL Fast Track designation for fibromyalgia in July 2024, expediting its review process to address this serious condition and unmet medical need. Publish Date: 16-10-2024   Source: Tonix Pharmaceuticals Holding Corp. Fibromyalgia (FM) presents a syndrome marked by persistent musculoskeletal pain, known as chronic musculoskeletal pain (CMP). The primary symptoms of FM encompass muscle stiffness, heightened general sensitivity, insomnia, persistent fatigue, mood disorders, cognitive impairment, anxiety, depression, joint stiffness, and an inability to perf...

 Fibromyalgia (FM) presents a syndrome marked by persistent musculoskeletal pain, known as chronic musculoskeletal pain (CMP). The primary symptoms of FM encompass muscle stiffness, heightened general sensitivity, insomnia, persistent fatigue, mood disorders, cognitive impairment, anxiety, depression, joint stiffness, and an inability to perform everyday tasks. Furthermore, FM can be linked to specific medical conditions, including infections, rheumatic disorders, diabetes, and psychiatric and neurological ailments. FM patients often exhibit a lowered pain threshold, leading to widespread hyperalgesia and allodynia. These phenomena indicate a problem related to pain amplification during sensory processing within the central nervous system (CNS). The diagnosis of FM is generally intricate due to the absence of distinct biochemical, imaging, or pathological characteristics. It is primarily determined through patient history and physical examination, with other diseases being ruled ou...

  Fibromyalgia (FM) is a syndrome characterized by chronic musculoskeletal pain (CMP). FM's main symptoms are muscle stiffness, general sensitivity, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, depression, joint stiffness, and the inability to carry out normal daily activities. FM can also be associated with specific diseases, such as infections, rheumatic diseases, diabetes, and psychiatric or neurological disorders. Patients with FM have a lower pain threshold, resulting in diffuse hyperalgesia and/or allodynia. This indicates an issue with pain amplifying with sensory processing in the CNS. The overall diagnosis of FM is complex because it has no specific biochemical, imaging, or pathological features. It is usually based on the results of anamnesis and physical examination and obtained by ruling out other diseases. However, the involvement of the immune neuroendocrine axis in this syndrome has prompted the study of th...