PharmaTher Inc (CSE: PHRM) this morning announced that it has filed a pre-investigational new drug meeting request, as well as having completed pre-IND briefing documents with that of the US Food and Drug Administration. The filings have been made in connection with the firms focus on clinical development of the use of ketamine in treating Parkinson’s Disease.
The filing that has been made by the company will also support the evaluation of a phase two clinical study on the use of ketamine to treat levodopa-induced dyskinesia that is associated with Parkinson’s Disease. The pre-IND meeting is viewed as a means of providing information to push forward with phase two clinical studies within the US.
Ketamine is currently an FDA-approved drug that contains a known safety profile. Preclinical data and case studies within Parkinson’s patients have shown that low doses of the compound have shown the potential to reduce levodopa-induced dyskinesia, which in layman terms is an involuntary movement disorder. The use of ketamine in such applications has also been indicated to reduce depression and improve on time.
“We are pleased to have taken this important step in advancing our ketamine program for Parkinson’s disease via the FDA regulatory pathway, which is part of our overall strategy of progressing our novel ketamine prescription-based therapies to treat neurological disorders for FDA approval. We look forward to finalizing our Phase 2 clinical study for ketamine in Parkinson’s disease and leveraging the pre-IND meeting to unlock additional value in our exclusive FDA-based ketamine programs in depression and pain.”
Fabio Chianelli, CEO of PharmaTher
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