Company aligned with FDA on key CMC topics Tonix also has completed the second and final pre-New Drug Application (NDA) meeting and discussed nonclinical, clinical pharmacology and clinical matters...
Treatment with Tonmya™ (TNX-102 SL, sublingual cyclobenzaprine HCl) in Phase 3 RESILIENT study significantly reduced daily pain and demonstrated broad fibromyalgia symptom improvement, as demonstrated...
Tonmya treatment was associated with improvement in depressive symptoms as measured by the Beck Depression Inventory-II In addition, post-hoc analyses showed improvement in depression, anxiety,...
In the Phase 2 PREVAIL trial in fibromyalgia-type Long COVID, bedtime TNX-102 SL resulted in a signal in fatigue, sleep and cognitive function Phase 2, investigator-initiated OASIS trial is designed...
Eight months after Tonix Pharmaceuticals announced its intentions to halt enrollment in the Phase III RALLY study following a futility analysis of the first 50% of patients, the company announced data that supported that decision.
Enforcement Report - Week of September 8, 2021
SAN DIEGO, Calif., Aug. 30, 2021 /PRNewswire/ -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced the presentation of scientific abstracts at two congresses, the 28th Annual Napa Pain Conference August 27-28th, 2021, and PAIN Week September 7-11th, 2021.
SAN DIEGO, Dec. 8, 2020 /PRNewswire/ -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced positive top-line results from the Phase 1 central nervous effects (CNS) clinical study of tolperisone. The study, utilizing a validated driving test, confirmed that tolperisone does not impair driving performance. In addition, tolperisone does not appear to cause sleepiness, a side effect often associated with currently available skeletal muscle relaxants.
 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 3 RALLY study (TNX-CY-F306) of TNX-102 SL 5.6 mg for the management of fibromyalgia.
Unichem Lab's Generic Cyclobenzaprine Hydrochloride Receives Approval in U.S