Psychotomimetic

VistaGen Therapeutics Receives FDA Clearance of IND for Phase 2 Clinical Study of AV-101 as a Potential Treatment of Dyskinesia in Parkinson's Disease Patients

Retrieved on: 
Thursday, January 30, 2020

The FDA's IND clearance permits VistaGen to proceed with Phase 2 clinical development of AV-101 in this indication.

Key Points: 
  • The FDA's IND clearance permits VistaGen to proceed with Phase 2 clinical development of AV-101 in this indication.
  • "Current drug treatment options for levodopa-induced dyskinesia, or LID, may cause serious side effects, including hallucinations and sedation.
  • In all clinical studies to date, AV-101 has not been associated with any psychotomimetic side effects or drug-related serious adverse events.
  • "These are important milestones for our AV-101 program, both a key regulatory advance and expanded commercial protection for AV-101 in the U.S.

Relmada Therapeutics Announces Completion of Dosing with REL-1017 in Phase 2 Study of Individuals with Treatment Resistant Depression

Retrieved on: 
Monday, July 29, 2019

None of the subjects experienced either serious adverse events or psychotomimetic adverse events, and no subject discontinued treatment because of safety or tolerability issues.

Key Points: 
  • None of the subjects experienced either serious adverse events or psychotomimetic adverse events, and no subject discontinued treatment because of safety or tolerability issues.
  • Thus far, the blinded data confirms the favorable safety and tolerability profile of REL-1017 previously observed in the Phase 1 studies.
  • We look forward to presenting top line data from this study by the end of Q3 2019."
  • Two Phase 1 studies previously demonstrated an overall favorable safety profile with no psychotomimetic adverse reactions, which are commonly associated with ketamine treatment.