Psycheceutical Announces Completion of Pre-IND Meeting with FDA for Topical Ketamine Drug to Treat PTSD
The FDA has given guidance to Psycheceutical regarding its development plans for preclinical studies required for an IND submission and the design of related Phase I and II clinical studies.
- The FDA has given guidance to Psycheceutical regarding its development plans for preclinical studies required for an IND submission and the design of related Phase I and II clinical studies.
- In 2023, Psycheceutical remains focused on completing the remaining IND-enabling studies that will support the IND submission and transition into Phase I and Phase II clinical studies.
- "We are undergoing a mental health epidemic, with millions suffering from conditions like PTSD with no current therapeutics on the market to help.
- We believe that NeuroDirect™ ketamine has the potential to be a life-altering treatment option that will provide profound benefits and relief to patients suffering from PTSD,” said Chad Harman, CEO of Psycheceutical.