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...

1. Investigating Ketamine for Parkinson’s Disease
By: Abby McVay
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.
If you need help with the FDA regulatory, quality, or compliance aspect of your product, EMMA
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1PharmaTher 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. https://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