VistaGen’s AV-101 Snags Fast Track Designation, Other Drugmakers Move Ahead with Non-Opioid Pain Treatment Programs


Opioids have shown tremendous efficacy in pain management. At the same time, the dangers of the addiction to the medication have become well-known in recent years as an epidemic has swept across the United States.

Last week, a pharmacist in Illinois warned me of the dangers of opioids as he filled a prescription for hydrocodone following a minor surgery. The pharmacist recommended taking acetaminophen for pain instead of the hydrocodone if that was possible – it was.

According to the National Institutes of Health, about 115 Americans die daily from overdosing on opioids, which includes illicit drugs, as well as prescription medications. As more and more patients, prescribers and pharmacists are recognizing the dangers of opioid-based pain medications, multiple companies are developing non-opioid treatments for pain. This week South San Francisco-based VistaGen Therapeutics snagged Fast Track designation from the U.S.Food and Drug Administration (FDA) for its neuropathic-pain candidate AV-101, the second such designation in the past year.
Neuropathic pain affects approximately 33 million people in the United States. It is characterized by a steady burning or sensation that results in abnormal neuronal function.

AV-101 is an investigational, orally bioavailable, small molecule NMDA (N-methyl-D-aspartate) receptor glycine B antagonist without psychological or sedative side effects, according to company data. In December, AV-101 was awarded the Fast Track designation for major depressive disorder. It is currently in Phase II development for that indication.

Shawn Singh, chief executive officer of VistaGen, said AV-101 has the potential to “address the high unmet need for a new non-opioid, non-sedating treatment for neuropathic pain.” He made that assertion based on peer-reviewed data published last year in The Journal of Pain coupled with data from the company’s Phase I clinical trial.

Singh pointed to the Fast Track designation awarded to AV-101 as a sign of the FDA’s commitment to addressing the opioid epidemic sweeping the nation.

“The FDA’s Fast Track designation for development of AV-101 for neuropathic pain, together with the previously granted Fast Track designation for major depressive disorder, will allow our team to work closely with the FDA to bring AV-101 to patients affected by two of our country’s most debilitating and widespread healthcare concerns as soon as possible,” Singh said in a statement.

VistaGen’s Fast Track designation comes about a month after the FDA and Commissioner Scott Gottlieb outlined plans for the regulatory agency to address opioid addiction. Part of that plan includes a new guidance to advance the development of non-addictive treatments for pain, which would include VistaGen’s AV-101, as well as other potential candidates. Earlier this year the FDA launched an “innovation challenge” to spur on the development of medical devices that can combat the crisis and help prevent and treat opioid use disorder – a disorder that is often caused by abuse of opioid-based pain treatments.

Other pharma and biotech companies are also focused on developing treatments for acute pain that do not use opioids, which BioSpace has highlighted in the past. For example, Connecticut-based Biowave’s non-opioid Smarter Pain Blocking Technology has been adopted for use by 32 veteran’s hospitals across the country. Likewise, startup Tremeau Pharmaceuticals is developing TRM-201 (rofecoxib), a highly potent cyclooxygenase-2 (COX-2) selective NSAID (nonsteroidal anti-inflammatory drugs) to treat hemophilic arthropathy (HA), a degenerative joint disease occurring in patients with hemophilia. Rofecoxib is a non-narcotic analgesic, unlike opioids, and has no effect on bleeding time relative to placebo.

Another non-opioid pain treatment in development is an NSAID spray. Pennsylvania-based Virpax Pharmaceuticals licensed MedPharm’s MedSpray ‘Patch-in-a-Can’ Technology as a non-opioid treatment for pain. The Patch-in-a-Can product, called DSF100 (NSAID spray film 1.3%), delivers an NSAID through a metered spray to the skin. The medicine is absorbed to target the pain. 

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