MMS Holdings announced that the company has successfully assisted Korea-based Vivozon in achieving a Fast Track Designation from the Food and Drug Administration (FDA) for VVZ-149, a non-opioid pain killer.
VVZ-149 is a new mechanism-based non-narcotic and non-NSAID analgesic demonstrating robust pain-suppressing efficacy in a panel of in vivo models (post-operative, formalin-induced, or neuropathic pain model), as well as substantial opioid sparing effects with excellent safety profiles in clinical trials to date.
"Given the global opioid crisis, meaningful alternatives are needed for patients who require effective pain relief, and we are honored to assist Vivozon in bringing this non-opioid pain killer one step closer to development and market availability," said Uma Sharma, Ph.D., Chief Scientific Officer, MMS. "I am proud of our internal regulatory experts for their aptitude and tenacity in gaining this status so quickly for Vivozon, just as they have routinely done for other sponsors."
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MMS has supported Vivozon in regulatory strategy, medical writing, project management, and quality control across several regulatory and clinical documents.
"MMS consistently provides our team with the highest level of detail and quality work in every task that they undertake," said Dr. Doo Lee, CEO and Head of Research and Development, Vivozon. "I am pleased that we were able to attain this fast track status and look forward to working with MMS as we continue into the phase three studies."
VVZ-149 has also shown the anti-itching effect in the serotonin-induced itching model. These in vivo efficacies are attributed to the synergistic or additive dual antagonistic activity of VVZ-149 against GlyT2 and 5HT2A which are key receptors for the transmission of the pain signal in the spinal dorsal horn area and/or peripheral sensory neurons.