Cyclobenzaprine
- Generic Name
- Cyclobenzaprine
- Brand Names
- Amrix, Fexmid, Flexeril
- Drug Type
- Small Molecule
- Chemical Formula
- C20H21N
- CAS Number
- 303-53-7
- Unique Ingredient Identifier
- 69O5WQQ5TI
- Background
Cyclobenzaprine, a centrally-acting muscle relaxant, was first synthesized in 1961 and has been available for human use since 1977. It was initially studied for use as antidepressant given its structural similarity to tricyclic antidepressants - it differs from Amitriptyline by only a single double bond. Since its approval, it has remained relatively popular as an adjunctive, short-term treatment for acute skeletal muscle spasms secondary to musculoskeletal injury.
- Indication
用于缓解与急性疼痛的肌肉骨骼疾病相关的肌肉痉挛（作为休息和物理治疗的辅助药）。但环苯扎林对脑、脊髓疾病或儿童脑性瘫痪引起的痉挛无效。
- Associated Conditions
- Muscle Spasms
First Patient Dosed in Phase 2 OASIS Trial of TNX-102 SL for Acute Stress Reaction Following Trauma
• Tonix Pharmaceuticals has initiated dosing in the Phase 2 OASIS trial evaluating TNX-102 SL for reducing acute stress reaction severity and acute stress disorder frequency following traumatic events.
• The investigator-initiated study, sponsored by UNC and supported by a $3 million DoD grant, will enroll approximately 180 motor vehicle collision survivors through emergency departments across the U.S.
• TNX-102 SL, a sublingual cyclobenzaprine formulation that has shown promise in improving sleep quality in PTSD patients, addresses a significant unmet need as no medications currently exist for immediate post-trauma treatment.
Tonix Pharmaceuticals Receives MCDC Grant to Advance TNX-801 Vaccine Against Smallpox and Mpox
• Tonix Pharmaceuticals has secured funding from the Medical CBRN Defense Consortium to develop TNX-801, a recombinant horsepox virus-based vaccine targeting both mpox and smallpox.
• The single-dose vaccine demonstrates improved tolerability compared to traditional vaccinia-based vaccines, with preclinical studies showing effectiveness against monkeypox amid ongoing global outbreaks.
• The grant will support comprehensive market analysis, target market identification, and commercialization planning for both government and private sectors.
Tonix's Fibromyalgia Treatment Shows Promising Phase 3 Results, FDA Decision Expected in 2025
• Tonix Pharmaceuticals' TNX-102 SL demonstrated statistically significant pain reduction in Phase 3 fibromyalgia trial, marking a potential breakthrough in treatment options.
• The FDA has scheduled a PDUFA date of August 15, 2025, for potential marketing approval of TNX-102 SL, setting a clear timeline for possible market entry.
• The company's positive developments, including new executive appointments and promising clinical data, have driven a remarkable 115% surge in stock value this week.
FDA Endorses Expanded Phase 3 Program for Tenax's Novel PH-HFpEF Treatment TNX-103
• Tenax Therapeutics receives FDA approval to expand its ongoing LEVEL study to 230 patients, increasing statistical power to over 95% for their oral levosimendan (TNX-103) trial in PH-HFpEF treatment.
• The company secured FDA agreement to initiate LEVEL-2, a second global Phase 3 study, with patient enrollment expected to begin in 2025, strengthening their clinical development program.
• Initial blinded data shows promising safety profile with over 95% patient retention and therapy continuation rates, supported by $100 million financing secured in August 2024.
TNX-1500 Shows Promising Safety Profile in Phase I Trial for Transplant Recipients
• Tonix Pharmaceuticals' TNX-1500, an anti-CD40L monoclonal antibody, demonstrated favorable safety and tolerability in Phase I trial with 26 healthy subjects across three dose cohorts.
• The drug showed effective immune modulation, successfully blocking anti-KLH antibody responses, with a half-life ranging from 19.6 to 37.8 days depending on dosage.
• Following positive results, Tonix plans to advance TNX-1500 to Phase II trials for kidney transplant recipients, with potential applications in preventing transplant rejection and treating autoimmune diseases.
Tonix Pharmaceuticals' TNX-102 SL Awaits FDA Decision for Fibromyalgia Treatment
• Tonix Pharmaceuticals' TNX-102 SL, a non-opioid analgesic, has been assigned an FDA PDUFA goal date of August 15, 2025, for fibromyalgia treatment, potentially offering a new option for millions.
• TNX-102 SL demonstrated significant pain reduction and improved sleep quality in Phase 3 trials, addressing key fibromyalgia symptoms with a well-tolerated safety profile.
• The FDA previously granted Fast Track designation to TNX-102 SL, highlighting the urgent need for innovative treatments for fibromyalgia, a condition affecting mostly women.
• If approved, TNX-102 SL could be the first in a new class of drugs for fibromyalgia in over 15 years, providing a novel approach to managing this chronic pain disorder.
Tonix Pharmaceuticals Submits NDA for TNX-102 SL for Fibromyalgia Treatment
• Tonix Pharmaceuticals has submitted an NDA to the FDA for TNX-102 SL, a non-opioid analgesic, seeking approval for fibromyalgia treatment.
• TNX-102 SL demonstrated statistically significant pain reduction in two Phase 3 trials, offering a potential new option for fibromyalgia patients.
• If approved, TNX-102 SL would be the first new drug for fibromyalgia in over 15 years, representing a novel tricyclic class of medicine.
• The FDA has granted Fast Track designation to TNX-102 SL, with a PDUFA date expected in 2025 for a decision on approval.
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