PharmaTher Holdings Ltd. PHRRF PHRMa leader in the pharmaceutical specialty ketamine, announced Friday that the phase 1/2 clinical study of ketamine in the treatment of Levodopa-induced dyskinesia in Parkinson’s disease was presented at the MDS International Congress on Parkinson’s and Movement Disorders in Madrid, Spain, reported Psychedelic Finance.
“We are pleased to present the first data from the Phase 1/2 ketamine study, demonstrating the safety and tolerability of ketamine with clinically meaningful efficacy, which warrants further investigation in a planned Phase 3 clinical trial as a potential novelty Treatment for levodopa-induced dyskinesia in patients with Parkinson’s disease supports,” said Fabio ChianelliCEO of PharmaTher.
“In light of these data and the recent US notification of approval of the patent application for ketamine as a potential treatment of Parkinson’s disease and motor disorders, we are now focused on obtaining an agreement with the FDA to grant 505(b)(2) approval pursue. regulatory pathway with a potential phase 3 clinical trial for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease,” added the CEO.
Highlights of the study
- Ketamine was safe and well-tolerated, with 100% of ketamine-treated patients showing a reduction in dyskinesia as measured by the Unified Dyskinesia Rating Scale (UDysRS).
- UDysRS showed a reduction of 51% from baseline during infusion 2 (p=0.003), 49% at 3 weeks (p=0.006), and 41% at 3 months (p=0.011) after ketamine.
- Planning a phase 3 clinical trial to allow for FDA approval KETARX (ketamine) for Parkinson’s disease under regulatory pathway 505(b)(2).
“The Phase 1/2 study was an open-label, dose-ranging study to test the safety, tolerability and pharmacokinetics of a low-dose ketamine infusion for the treatment of levodopa-induced dyskinesia (“LID”) in Parkinson’s disease and to find an effective dose range , suitable for outpatient use. That…
