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.