Neuropathic pain is a complex, chronic pain state that results from problems with signals from nerves. There are various causes of neuropathic pain, including tissue injury, nerve damage or disease, diabetes, infection, toxins, certain types of drugs, such as antivirals and chemotherapeutic agents, certain cancers, and even chronic alcohol intake. With neuropathic pain, damaged, dysfunctional or injured nerve fibers send incorrect signals to other pain centers and impact nerve function both at the site of injury and areas around the injury. Many neuropathic pain treatments on the market today, including gabapentin, have side effects such as anxiety, depression, mild cognitive impairment and/or sedation.
In published peer-reviewed studies, titled: "Characterization of the effects of L-4-chlorokynurenine on nociception in rodents," by lead author, Tony L. Yaksh, Ph.D., Professor in Anesthesiology at the University of California, San Diego, was published in The Journal of Pain in April 2017 (DOI: 10.1016/j.jpain.2017.03.014), systemic delivery of AV-101 resulted in robust, dose-dependent anti-nociceptive effects, similar to gabapentin (a commonly used drug for neuropathic pain that causes sedation and mild cognitive impairment), but with no sedative or other discernable negative side effects.
The FDA has granted Fast Track designation to AV-101 for development as a new orally-available, non-sedating, non-opioid alternative to treat debilitating neuropathic pain for the millions of patients suffering without relief from current medications.