Investigational Dyskinesia Treatment Gets FDA Green Light

February 4, 2020

The FDA has approved the investigational new drug application for AV-101 for the treatment of dyskinesia in patients with Parkinson disease who are treated with levodopa.

This article was originally published on HCPLive, part of the HCPLive Network.

Shawn Singh

Investigational dyskinesia treatment AV-101 has been given the go-ahead by the FDA for a phase 2 clinical trial in patients with Parkinson disease who are receiving levodopa therapy.

The drug, developed by VistaGen Therapeutics, is an NMDAR (N-methyl-D-aspartate receptor) glycine site antagonist.

VistaGen also received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a US Patent Application 16/003,816 related to therapeutic use of AV-101 for treatment of dyskinesia induced by the administration of levodopa. If issued, the patent will be in effect until at least 2034.

Investigators presented preclinical data during the 7th International Conference on Parkinson’s and Movement Disorders in London showing that the treatment reproduced motor complications of the disease in non-human primate models, including dyskinesia observed in Parkinson disease patients treated with levodopa. In the MPTP primate model, the antidyskinetic activity of the new treatment compared favorably with prior observations with amantadine in parkinsonian monkeys. AV-101 was favorable to amantadine, which comes with known side effects.

In the study, the new drug’s efficacy against levodopa-induced dyskinesia was measured through behavioral scores on a dyskinesia scale, as well as a parkinsonian disability scale to measure levodopa antiparkinsonian efficacy. The study demonstrated that AV-101 significantly (P = .01) reduced levodopa-induced dyskinesia without affecting the timing, extent, or duration of the therapeutic benefits of levodopa.

“Current drug treatment options for levodopa-induced dyskinesia may cause serious side effects, including hallucinations and sedation,” Shawn Singh, chief executive officer of VistaGen, said in a statement. “In all clinical studies to date, AV-101 has not been associated with any psychotomimetic side effects or drug-related serious adverse events.”

REFERENCE

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 [news release]. South San Francisco, CA: VistaGen Therapeutics. January 3, 2020. vistagen.com/news-media/press-releases/detail/133/vistagen-therapeutics-receives-fda-clearance-of-ind-for. Accessed January 3, 2020.