100% of patients treated with ketamine showed a decrease in dyskinesia as measured by the Unified Dyskinesia Rating Scale.
Ketamine is well tolerated and no serious adverse events have been reported
The study results are sufficient to provide an empowering effect size for Phase 3 clinical studies.
PharmaTher is planning a Phase 3 clinical trial to enable FDA approval of KETARX ™ (ketamine) for Parkinson’s disease based on the 505 (b) (2) regulatory pathway.
Toronto, March 23, 2022 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (“Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine medicines, is on the positive top line. I am happy to announce the results. From dose setting and tolerable clinical studies (“Studies”) of ketamine for the treatment of levodopa-induced dyskinesias (“LID”) in patients with Parkinson’s disease. The study results are sufficient to provide effect size in promoting Phase 3 clinical studies, which can bridge the design with extended treatment periods compared to the company’s Phase 2 clinical studies (NCT04912115). Expected.
This study evaluated the safety, tolerability, and efficacy of low-dose ketamine infusion in the treatment of LID in patients with Parkinson’s disease. Efficacy data from the study showed that 100% of patients treated with ketamine showed a reduction in dyskinesia as measured by the Unified Dyskinesia Rating Scale during the study period compared to pretreatment baseline. rice field. Safety data from this study show that ketamine is well tolerated and no serious adverse events have been reported. All adverse events were mild or moderate and reflected the expected side effects of ketamine administration. This study was previously discovered in an observational study publication entitled “Case reports showing the long-term effects of anesthetized ketamine infusion on the reduction of l-dopa-induced dyskinesias” on the positive effects of ketamine on the reduction of LID. Further support. The full results of the study will be submitted for presentation at the Medical Conference by June 2022.
Dr. Scott Sherman, Principal Investigator of the Research, commented: This opens the door to the rapid development of new non-surgical treatments for levodopa-induced dyskinesias that fill the large gaps in existing therapeutic weapons. Dr. Scott Sherman is an associate professor of neurology at the University of Arizona School of Medicine, director of the Center for Movement Disorders, director of medical care at the Arizona branch of the American Parkinson’s Disease Association, and director of the Parkinson’s Disease Program at the Health South Rehabilitation Institute. am. Of Tucson.
Fabio Chianelli, CEO of PharmaTher, commented: 505 (b) (2) Potential Phase 3 clinical trials to support FDA approval via regulatory pathways. “
Based on the findings of the study, we establish the next step in a phase 3 clinical study planned to enable approval of ketamine for Parkinson’s disease under the 505 (b) (2) regulatory pathway. I am preparing to sign a contract with the FDA. We plan to use our unique intravenous ketamine product, KETARX ™, for planned Phase 3 clinical trials.
Potential of ketamine in Parkinson’s disease
Parkinson’s disease is a debilitating disorder that affects more than 1 million people in the United States and more than 7 million people worldwide. The global Parkinson’s disease market is expected to grow from $ 5 billion in 2019 to $ 7.5 billion by the end of 2025. [360iResearch 2020] In addition, the potential market opportunity for LID Parkinson’s disease is estimated to exceed US $ 3 billion in the United States alone.
Ketamine is an FDA-approved N-methyl-D-aspartate receptor regulator (NDMA) drug that is widely used as an anesthetic, either alone or in combination with other anesthetics. [Smith et al, 1987; Pacheco et al, 2014].. The possible therapeutic effect of low-dose ketamine on levodopa-induced dyskinesia was noted in a retrospective analysis of Parkinson’s disease patients who received ketamine for pain relief.During this analysis, it was observed that patients experienced an improvement in LID that lasted several weeks after treatment. [Sherman et al, 2016].. These results are supported by a low-dose ketamine study in a rodent LID model, and this possible effect is also being investigated in controlled studies. [Bartlett et al, 2016]..Ketamine may also have additional benefits in the treatment of pain [Niesters et al, 2014] Depression [Diamond et al, 2014; Murrough et al, 2013]A frequent comorbidity of Parkinson’s disease.
About Parkinson’s disease
Several drug combinations have been used to treat the symptoms of Parkinson’s disease, but there is currently no cure for Parkinson’s disease. The etiology of Parkinson’s disease is not fully understood, but is thought to be due to the loss of substantia nigra pigmented dopaminergic neurons and their striatal processes, leading to striatal dopamine deficiency. [Schapira and Jenner, 2011].. This ultimately affects the cortical striatal system that controls movement.As a progressive nervous system disorder of the central nervous system that primarily affects the motor nervous system, symptoms of Parkinson’s disease appear slowly and may include tremor, stiffness, bradykinesia, and postural instability. [Paulson and Stern, 2004].. Patients may also experience non-motor symptoms such as autonomic dysfunction (orthostatic hypotension, constipation, bladder dysfunction), psychiatric (depression), cognitive and sensory symptoms (pain). [Olanow, et al, 2009].. These non-motor symptoms become more common as the disease progresses. Treatments that include levodopa and dopamine agonists to relieve dopamine deficiency in the brain have been used for almost 50 years. However, continuous treatment with levodopa often has the side effects of dose-limited exercise. This includes the appearance of an abnormal involuntary movement called levodopa-induced dyskinesia. This can be seen in about 50% of patients within 5 years of starting levodopa treatment and in almost all patients within 10 years of starting treatment. These side effects often limit further dose increases in dopaminergic therapy.
There is no guarantee that the FDA will support the potential demand for approval of ketamine in the treatment of Parkinson’s disease or a rapid path to further development.
About PharmaTher Holdings Ltd.
PharmaTherHoldings Ltd. (OTCQB: PHRRF) (CSE: PHRM) focuses on the development and commercialization of specialized ketamine medicines for mental health, neurological and painful disorders. For more information, PharmaTher.com..
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PharmaTher announces positive top-line results from clinical studies of ketamine for Parkinson’s disease, Canadian Business Journal
Source link PharmaTher announces positive top-line results from clinical studies of ketamine for Parkinson’s disease, Canadian Business Journal