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 granted the company a pre-investigational new drug meeting. The meeting, which was filed for earlier this week, is in connection with the clinical development of ketamine for use against Parkinson’s Disease, as well as a currently proposed phase 2 clinical study for using the psychedelic compound in the treatment of levodopa-induced dyskinesia associated with Parkinson’s.

The current timeline for the written response meeting indicates that the meeting should be conducted by the end of January 2021. Furthermore, PharmaTher has stated that it has substantially completed its application for an investigational new drug, and upon receiving responses from the FDA, intends to file and begin a phase 2 study on the use of ketamine for the treatment of levodopa induced dyskinesia, or the loss of motor controls, within the first quarter of 2021.

The meeting to be conducted with the FDA is anticipated to provide the required information to submit this application, and enable the company to continue along the FDA regulatory pathway.

“We are pleased that our initiatives focused on the FDA regulatory pathway for ketamine continues its momentum and the IND builds a foundation where we can develop an FDA approved ketamine for not only Parkinson’s disease, but also for the millions of people worldwide affected by movement disorders, depression and pain.”

Fabio Chianelli, CEO of PharmaTher

PharmaTher last traded at $0.27 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

Avino Q2 Earnings: Steady As She Goes

MEG Energy: Cenovus Comes In With $7.9 BILLION Offer

Orla Mining Q2 Earnings: Musselwhite Changes Everything

Recommended

Northern Superior Expands Philibert With 350 Metre Step Out Testing 1.10 g/t Gold Over 25.5 Metres

Goliath Resources Hits 18.58 g/t Gold Over 5.00 Metres At Surebet

Related News

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

PharmaTher, Revive, Complete Psilocybin Intellectual Property Transaction

PharmaTher (CSE: PHRM) has seen the completion of the sale of its psilocybin program to...

Wednesday, February 17, 2021, 09:58:18 AM

Tobacco (Finally) Falls Out of Favor As Legal Marijuana Continues to Gain Public Support

American society is witnessing a remarkable shift in attitudes toward cannabis and tobacco. Once upon...

Monday, March 13, 2023, 08:09:52 AM

Revive Therapeutics, Pharmather Partner On Psilocybin Cancer Research

Revive Therapeutics (CSE: RVV) and Pharmather Inc (CSE: PHRM) this morning jointly announced a research...

Wednesday, November 18, 2020, 07:30:40 AM

Mass Layoffs Hit FDA, CDC and Other Health Agencies

The Trump administration has initiated sweeping layoffs at key US health agencies, with approximately 10,000...

Wednesday, April 2, 2025, 02:19:00 PM