Investigating Ketamine for Parkinson’s Disease

by | Jun 23, 2021 | Clinical Trials, FDA, Genetics, Medicine, Pharmaceuticals, Product Development

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 International’s team of experts has you covered. Contact us at 248-987-4497, or email info@emmainternational.com today!

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

Abby McVay

Abby McVay

Research Analyst- Ms. McVay is EMMA International’s Research Analyst. She has experience in technical writing and clinical trials in many life science industries. She has experience with many different elements of quality and regulatory compliance. Ms. McVay holds a Bachelor of Science in Psychology from Manchester University as well as a Master of Science in Industrial and Organizational Psychology from Angelo State University.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This