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
Drug firm Unichem Laboratories on Tuesday said it has received approval from the US health regulator to market its Cyclobenzaprine Hydrochloride tablets used for relief of muscle spasm in the American market. The company has received abbreviated new drug application (ANDA) approval to market its Cyclobenzaprine Hydrochloride tablets USP 5 mg, 7.5 mg and 10 mg from the United States Food and Drug Administration (USFDA), Unichem LabsNSE 3.11 % said in a filing to the BSE.
Unichem Laboratories has received ANDA approval for its Cyclobenzaprine Hydrochloride Tablets USP, 5 mg, 7.5 mg and 10 mg from the United States Food and Drug Administration (USFDA) to market a generic version of FLEXERIL (Cyclobenzaprine HCI) Tablets, 5 mg and 10 mg of Janssen Research and Development LLC.
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NEW YORK, April 24, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that 50 percent of the planned total number of participants have been randomized in the Phase 3 RELIEF trial, a potential pivotal study of TNX-102 SL* (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, centrally acting analgesic, taken daily at bedtime for the management of fibromyalgia.