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.
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