Friday, June 13, 2025

Latest

PharmaTher Receives FDA Approval For Ketamine Trial For Parkinson’s

PharmaTher Holdings (CSE: PHRM) has seen the US FDA approve the firms application for an investigational new drug. The approval relates to a phase 2 clinical trial to evaluate the use of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.

With the approval now in hand, the company currently anticipates that it will begin enrolling patients in the phase two trial in the third quarter of 2021. From here, if results prove positive, the company will then request a meeting with the FDA to obtain an agreement to move ahead with phase 3 studies under the 505(b)(2) regulatory pathway next year.

The trial, entitled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease,” is expected to involve up to eight clinical sites in the US. The company will look to randomize a total of up to 36 patients to either ketamine or midazolam, the active control under the study.

Patients are to be monitored for a period of eight weeks, and graded on the Unified Dyskinesia Rating Scale, with the ultimate goal of determining the improvement in the patients quality of life.

“The FDA’s acceptance of our IND application for ketamine to treat Parkinson’s disease is a significant milestone for us. The FDA IND is our first of many we will aim to obtain, and we are one of the few psychedelics-focused biotech companies that have an IND approved by the FDA for a recognized psychedelic drug.”

Fabio Chianelli, Chief Executive Officer of PharmaTher

PharmaTher Holdings last traded at $0.19 on the CSE.


FULL DISCLOSURE: Pharmather is a client of Canacom Group, the parent company of The Deep Dive. The author has been compensated to cover Pharmather on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security.

Video Articles

Aznalcóllar Corruption Case Nears Conclusion | David Gower – Emerita Resources

Why Precious Metals Crashed on Trump’s Trade Deals? | Jesse Day

Big Gold Miners Don’t Trust $3,300 Gold, Do They See a Crash Ahead? | Rob McEwen

Recommended

NexGen Energy Receives Approval For Site Expansion At Rook I Project

ESGold Sees Installation Of Humphrey Spirals Completed At Montauban

Related News

FDA Grants PharmaTher Pre-IND Meeting For Treatment Of Parkinson’s With Ketamine

PharmaTher Inc (CSE: PHRM) this morning announced that the US Food and Drug Administration has...

Thursday, December 10, 2020, 09:04:12 AM

PharmaTher Collaborates For Research On Psychedelic Microdosing Tech

PharmaTher Inc (CSE: PHRM) this morning announced that it will be conducting further research related...

Tuesday, February 23, 2021, 07:25:33 AM

PharmaTher Submits For Phase 2 Clinical Trial With FDA

PharmaTher Holdings (CSE: PHRM) is looked to complete a phase two clinical trial. The company...

Tuesday, April 20, 2021, 07:38:21 AM

PharmaDrug JV Submits Application For Phase 1 Clinical Trials In Australia

PharmaDrug Inc (CSE: DRUG) has seen one of its joint ventures advance to the clinical...
Wednesday, May 15, 2024, 09:17:48 AM

Pharmather Appoints Dr Alberto J Espay As Scientific Advisor

Pharmather Inc (CSE: PHRM) has appointed a prolific Parkinson’s researcher to its team of scientific...

Wednesday, November 11, 2020, 08:29:13 AM