PharmaTher Holdings Ltd. PHRRF‘s recent meeting with the FDA on the feasibility of a Phase 3 program for proprietary ketamine KETARX for the treatment of levodopa-induced dyskinesia in Parkinson’s disease (LID-PD) was successful with federal agency support for the company’s overall approach.
There is currently no cure for this progressive neurodegenerative disease, although some drug combinations are used to treat its symptoms, including levodopa and dopamine agonists, which restore the brain’s dopamine deficit but have motor side effects that limit dose increases after a certain point.
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PharmaTher would then submit an IND application under that 505(b)(2) regulatory pathway following positive results from a single confirmatory study. In addition, the FDA advised the company to submit a fast-track regulatory submission.
Previous safety and efficacy results from its Phase 1/2 clinical trial of KETARX for the treatment of LID-PD will be used to advance trials into the proposed Phase 3 clinical phase.
These results showed Ketamine was safe, well tolerated, and reduced dyskinesia in all study participants who had moderate to advanced Parkinson’s disease prior to study entry.
PharmaTher was previously granted a letter of acceptance by the USPTO for its patent on compositions and methods for the treatment of motor disorders, which covers its patent proprietary ketamine for treatment Parkinson’s and other motor disorders and expects the patent to be granted in the coming months.
PCC by Benzinga
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