In the News: Ketamine for Parkinson's and Motor Disorders
PharmaTher recently announced that the United States Patent and Trademark Office (USPTO) has provided a Notice of Allowance for its patent application. This patent includes claims intended to cover Ketamine in the potential treatment of Parkinson’s Disease and motor disorders that cause involuntary or uncontrollable movement or actions of the body.
A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application. A patent from the recently allowed application is expected to be issued in the coming months.
Clinical Study Related to Ketamine and Parkinson’s
PharmaTher has been exploring the use of Ketamine as a potential treatment of Parkinson’s disease. A clinical study evaluated the safety, tolerability and efficacy of low-dose Ketamine infusion for the treatment of levodopa-induced dyskinesia (uncontrolled, involuntary movements) in patients with Parkinson’s disease. Efficacy data from the study demonstrated that 100% of patients treated with Ketamine demonstrated a reduction in dyskinesias as measured by the Unified Dyskinesia Rating Scale during the study period compared to the pre-treatment baseline.
Safety data from the study demonstrated that Ketamine was well tolerated with no serious adverse events reported. All adverse events were mild or moderate and reflected the expected side-effects of ketamine administration.
This study further supports the previous findings in the observational study publication, titled “Case Reports Showing a Long-Term Effect of Subanesthetic Ketamine Infusion in Reducing l-DOPA-Induced Dyskinesias,” regarding the positive impact of Ketamine in reducing LID.
Based on the study results, the Company is preparing to engage the FDA to establish the next steps for a planned Phase 3 clinical study to allow for Ketamine’s approval for Parkinson’s disease under the 505(b)(2) regulatory pathway.