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>>> VistaGen Announces Positive Preclinical Data Supporting AV-101's Potential for Treating Neuropathic Pain Comparable to Pregabalin (Lyrica(R)), without its Side Effects


Accesswire

May 30, 2019


https://finance.yahoo.com/news/vistagen-announces-positive-preclinical-data-123000499.html


New preclinical data involving pregabalin are consistent with peer-reviewed data involving gabapentin previously published in The Journal of Pain


SOUTH SAN FRANCISCO, CA / ACCESSWIRE / May 30, 2019 / VistaGen Therapeutics (VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for depression, social anxiety disorder and other central nervous system (CNS) diseases and disorders with high unmet need, today announced positive results of recent preclinical studies of the effects of AV-101, VistaGen's oral NMDA receptor glycine site antagonist, compared to pregabalin (Lyrica®1) in the Chung ligation model of pain, an accepted gold standard preclinical model for chronic neuropathic pain caused by nerve damage.

These preclinical studies were conducted under contract in the laboratory of Tony L. Yaksh, Ph.D., Professor in Anesthesiology at the University of California San Diego School of Medicine. This work demonstrated that AV-101 had a significant dose-response with similar efficacy in a rat model of a mononeuropathy as compared to pregabalin (Lyrica), which was used as an active comparator. Similar positive results involving AV-101 in this preclinical model, but using gabapentin (Neurontin®2) as an active control, were previously peer-reviewed and published in The Journal of Pain3. Detailed results of these new studies will be presented at an upcoming scientific conference.

"In this new preclinical study examining AV-101's analgesic and behavioral profile compared to pregabalin, AV-101 demonstrated robust analgesic effects, similar to pregabalin, but fewer side effects as measured in the rotarod assay," reported H. Ralph Snodgrass, Ph.D., VistaGen's Chief Scientific Officer. "This study provides further support of AV-101's potential to treat debilitating neuropathic pain, without causing the burdensome side effects and safety concerns associated with the medications currently used by millions of Americans to treat neuropathic pain, such as drowsiness, dizziness and risk of abuse."

The U.S. Food and Drug Administration has granted Fast Track designation for the development of AV-101 as a non-opioid treatment of neuropathic pain.

About Neuropathic Pain

Neuropathic pain (NP) affects approximately 33 million people in the United States (excluding patients with back pain).4 It is characterized by a steady burning "pins and needles" or "electric shock" sensation that results in abnormal neuronal function after nerve damage resulting from traumatic injuries, viral infections, certain medications, or metabolic conditions such as diabetes. Current treatments for neuropathic pain include antidepressants, anticonvulsants (such as gabapentin and pregabalin), and opioids, among others. However, current medications may offer inadequate efficacy, have limiting side effects, and be associated with abuse.

About AV-101

AV-101 (4-Cl-KYN) belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA glutamate receptor modulators. The NMDA receptor is a pivotal receptor in the brain and abnormal NMDA function is associated with multiple CNS diseases and disorders, including chronic neuropathic pain, epilepsy, major depressive disorder, Parkinson's disease levodopa-induced dyskinesia and many others. AV-101 is an oral prodrug of 7-Cl-KYNA which binds uniquely at the glycine site of the NMDA receptor and has potential to be a new at-home treatment for multiple CNS indications with high unmet need. The FDA has granted Fast Track designation for development of AV-101 as both a potential adjunctive treatment for MDD and as a non-opioid treatment for neuropathic pain.

About VistaGen

VistaGen Therapeutics is a clinical-stage biopharmaceutical company developing new generation medicines for depression, social anxiety disorder and other CNS diseases and disorders with high unmet need. VistaGen's pipeline includes three CNS drug candidates, AV-101, PH10, and PH94B. For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

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