Specialty pharmaceutical company PharmaTher Holdings PHRRF has submitted a Fast Track Application to the Food and Drug Administration (FDA) for KETARX, a ketamine drug that may help treat levodopa-induced dyskinesia in Parkinson’s disease.
Fast Track designation is for drugs designed to address serious or life-threatening conditions and can expedite development and review. KETARX has previously been found safe, well-tolerated and effective in reducing dyskinesias in Parkinson’s patients in Phase I/II clinical studies.
The results of that 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, with one million in the U.S.
Ketamine, an FDA-approved substance used for anesthetic purposes, may hold 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 patients. PharmaTher owns US Patent No: 11,426,366, which covers the use of ketamine in the treatment of Parkinson’s and other motor disorders.