Neurana Pharmaceuticals has concluded subject enrolment in a Phase III nRESUME-1 clinical trial of its therapy, tolperisone, to treat muscle nspasms linked to acute, painful musculoskeletal conditions.
The Drugs Controller General (India) has directed the State drug controllers to restrict the fixed dose combination (FDC) tolperisone HCI 150 mg+ paracetamol IP 500 mg tablet only for symptomatic treatment of post-stroke spasticity associated with pain in adults, and direct the manufacturers to submit phase IV clinical trial data on revised indication.
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, June 7, 2021 /PRNewswire/ -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced that 500 of its target 1,000 subjects have been enrolled in the Phase 3, RESUME-1 clinical study of tolperisone, a novel, non-opioid, centrally acting muscle relaxant in clinical development for the treatment of symptoms associated with acute and painful muscles spasms of the back.
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.
Katama Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of products focused on the unmet therapeutic needs of the central nervous system, today announced receipt of a Notice of Allowance of a Composition of Matter patent for a novel form of tolperisone, an approved product outside the United States that has demonstrated improvement in the treatment of skeletal muscle disorders without sedation. Tolperisone is subject to a composition of matter patent that has been issued in Canada.