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New Non-Opioid Treatment for Neuropathic Pain


New Non-Opioid Treatment for Neuropathic Pain

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of AV-101 as a non-opioid, non-sedating treatment for neuropathic pain, announced VistaGen Therapeutics, a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders.

AV-101 is an investigational, orally bioavailable, small molecule NMDA (N-methyl-D-aspartate) receptor glycine B antagonist. According to the Company, AV-101 has the potential to achieve ketamine-like antidepressant effects, but without the side effects and safety concerns. AV-101 has the potential to be a new at-home treatment for multiple CNS indications with high unmet need.

Read Also: Repeated lidocaine infusion effective in refractory neuropathic pain

“Every day in the U.S., more than 115 people die from overdosing on opioids. We have evaluated AV-101 in multiple models of serious CNS conditions, including those that cause patients to suffer from neuropathic pain, for which current treatment options are inadequate. After considering peer-reviewed data published last year in The Journal of Pain, together with published safety data from our Phase 1 program, we believe AV-101 has the potential to address the high unmet need for a new non-opioid, non-sedating treatment for neuropathic pain,” said Shawn Singh, Chief Executive Officer of VistaGen.

The treatment is currently being evaluated in a Phase 2 study (ELEVATE) in patients with a major depressive disorder who have had an inadequate response to standard antidepressant therapy (ie, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors).

The FDA’s Fast Track designation is designed to facilitate the development, and potentially expedite the review, of drugs to treat serious or life-threatening conditions and fill an unmet medical need.

Neuropathic pain (NP) is characterized by a steady burning or “pins and needles” or “electric shock” sensation that results in abnormal neuronal function after trauma to the nerve, viral infections, certain medications, or metabolic insults.

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Vinay Singh

Vinay Singh

Vinay Singh joined Medical Dialogue as Desk Editor in 2018. He covers the medical speciality news in different medical categories including Medical guidelines, updates from Medical Journals and Case Reports. He completed his graduation in Biotechnology from AAIDU and did his MBA from IILM Gurgaon. He can be contacted at editorial@medicaldialogues.in . Contact no. 011-43720751
Source: press release

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