Vivozon’s Non-Opioid Pain Killer has been granted the FDA’s Fast Track Designation through Regulatory Strategy Support from MMS
CANTON, Mich. (November 8, 2018) – MMS Holdings Inc. (MMS) – an award-winning, data-focused CRO – announced that the company has successfully assisted Korea-based Vivozon Inc. 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.”
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.
Learn more about VVZ-149 at http://www.vivozon.com/
MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.
Vivozon, Inc. is specialized in the discovery, development and commercialization of the small molecule drugs for the treatment of patients with the unmet CNS medical needs by applying the innovative approach to rapidly identify the lead compounds using its unique ex vivo/phenotypic screening technology. The company is focused on the development of the safe non-opioid-next-generation pain killer for the patients suffering from operations, neuropathic pain, cancer pain, etc. Vivozon’s lead drug candidate, VVZ-149, is currently in the phase 2b clinical trials (Korea and USA) for the treatment of post-operative pain. Currently, two back-up programs of second and third generation of VVZ-149 are active with many hits and new lead molecules. After the 10-years of service at the global big pharma in the U.S. as a research scientist in the department of neuroscience, Dr. Doo Lee, along with Professor Kyung-Woon Jung of USC (Department of Chemistry), CA, USA, has founded Vivozon in 2008. The company is actively running the drug discovery programs for the CNS indications based upon the ex vivo/phenotypic screening technology developed by Dr. Lee. For more information, visit: http://www.vivozon.com
Don McLean, MBA