In May 2021, the FDA approved an Investigational New Drug (IND) application from PharmaTher Holdings Ltd., to proceed with a Phase Two clinical trial. PharmaTher Holdings Ltd. is a psychedelics biotech organization that focuses on research and development, and commercialization of psychedelics to treat pain and neurological disorders, and mental illnesses. This company is headquartered in Vancouver, Canada.
The Phase Two clinical trial will evaluate and establish the efficacy, safety, and pharmacokinetics of ketamine to treat patients with Parkinson’s disease. PharmaTher plans to begin the trial in the third quarter of 2021.
Parkinson’s disease is a disorder that affects over one million individuals in the United States alone, and more than seven million worldwide. Parkinson’s disease is a neurogenerative disorder that affects the central nervous system, especially the motor nerve system. Symptoms of Parkinson’s emerge slowly and include postural instability, tremors, cognitive and sensory problems, and automatic dysfunction, like hypotension. Currently, there is no cure for Parkinson’s disease. There are drug combinations that help decrease the disease’s symptoms and side effects.
Ketamine is an FDA-approved NMDA, or N-Methyl-D-Aspartate, which is a receptor-modulating drug utilized as an anesthetic agent. There was a therapeutic effect of ketamine on patients who have Parkinson’s disease. Ketamine also has additional benefits in treating symptoms of Parkinson’s disease, like pain and depression, which are frequent comorbidities of Parkinson’s disease.
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1 PharmaTher Holdings Ltd. (2021, May 17). PharmaTher Announces FDA Approval of Ketamine IND In The Treatment of Parkinson’s Disease. GlobeNewswire News Room; PharmaTher Holdings Ltd. ttps://www.globenewswire.com/news-release/2021/05/17/2230622/0/en/PharmaTher-Announces-FDA-Approval-of-Ketamine-IND-In-The-Treatment-of-Parkinson-s-Disease.html