Specialized pharmaceutical company PharmaTher stocks PHRRF has submitted a fast track application to the Food and Drug Administration (FDA) for KETARXa ketamine drug that may help treat levodopa-induced dyskinesia in Parkinson’s disease.
Fast track status applies to drugs that are being developed to treat serious or life-threatening conditions and can expedite development and review. KETARX has already been shown in Phase I/II clinical trials to be safe, well tolerated and effective in reducing dyskinesia in Parkinson’s disease patients.
Results from this study will support PharmaTher’s planned Phase 3 clinical trial, which is being designed in response to FDA recommendations. Ketamine has the potential to treat Parkinson’s and other motor disorders.
Ketamine brings hope to Parkinson’s patients
Parkinson’s disease, for which there is no cure, affects up to 10 million people worldwide, including one million in the United States
ketaminean FDA-approved substance used for anesthetic purposes may show promise as a treatment for levodopa-induced dyskinesia, according to a retrospective analysis of patients who received it for pain relief.
Low-dose ketamine may also help treat pain and depression, which are common comorbidities in Parkinson’s disease patients. PharmaTher owns US Patent No. 11,426,366 covering the use of ketamine in the treatment of Parkinson’s and other motor disorders.