Macleods Pharma`s Generics Cyclobenzaprine HCl Receives Approval in US
Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia Approximately 10 million adults in the U.S. are affected by fibromyalgia, predominantly...
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.