AV-101 has previously gained fast track status to treat neuropathic pain. Credit: Zay Nyi Nyi/Shutterstock.

The US Patent and Trademark Office (USPTO) has granted a patent to Vistagen’s non-opioid oral product candidate, AV-101 for neuropathic pain treatment.

This patent is set to remain in effect until at least 2034 and is a key addition to the company’s worldwide patent portfolio, covering AV-101’s therapeutic uses and manufacturing methods in treating disorders that involve the N-methyl-D-aspartate (NMDA) receptor – an ionotropic glutamate receptor i the brain.

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Vistagen CEO and president Shawn Singh stated: “This new patent advances our AV-101 portfolio and significantly strengthens our position for potential collaborative development and commercialisation of this clinical-stage product candidate.

“We look forward to identifying potential partnering opportunities for AV-101 as a non-opioid alternative for pain, as well as dyskinesias and other neurological disorders.”

Preclinical data of a study, conducted by the University of California, San Diego’s anaesthesiology and pharmacology professor Dr Tony Yaksh, has shown that the therapy exhibits robust antinociceptive effects.

AV-101 demonstrated similarly strong anti-nociceptive effects to the control drugs tested (gabapentin and MK-801), but unlike the control drugs, the non-opioid AV-101 showed no noticeable negative side effects.

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Further research by Dr Yaksh compared the therapy to pregabalin, leveraging the Chung ligation pain model.

The findings indicated that AV-101 had a dose-response and similar efficacy in the rat model compared to the active comparator, pregabalin, suggesting its potential in treating several hyperpathic pain conditions.

The company is seeking strategic partnerships to commercialise the therapy and progress it to clinical development, with a focus on pain and dyskinesias.

AV-101 has gained fast track status from the US Food and Drug Administration to treat neuropathic pain and as an adjunctive therapy for major depressive disorder.

In addition to AV-101, the company received several new patents for PH80, a neuroactive pherine nasal spray for migraine treatment, in July 2024.