PharmaTher Holdings Ltd. (OTCQB:PHRRF)'s recent meeting with the FDA on the feasibility of a Phase 3 program for proprietary ketamine KETARX to treat levodopa-induced dyskinesia in Parkinson's disease (LID-PD) was successful, considering the federal agency supported the company's overall approach.
Currently, there is no cure for this progressive neurodegenerative disorder, although some drug combinations are used to treat its symptoms, including levodopa and dopamine agonists which restore the brain's dopamine deficits but carry on motor-side effects that limit dose increases after a certain point.
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PharmaTher would then submit an IND application under the 505(b)(2) regulatory pathway following positive results from a single confirmatory trial. Further, the FDA advised the company to submit a Fast Track designation application.
Prior safety and efficacy results from its Phase 1/2 clinical trial on KETARX for the treatment of LID-PD will be used to advance studies into the proposed Phase 3 clinical stage.
Those results showed ketamine was safe, well-tolerated and provided a reduction in dyskinesias in all study participants, who had moderate to advanced Parkinson's prior to the study's commencement.
PharmaTher was previously granted a notice of allowance by the USPTO for its patent on compositions and methods for treating motor disorders covering its proprietary ketamine for the treatment of Parkinson's and other motor disorders and expects to get the patent issued in the coming months.
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