#South Korea #Seoul #VIVOZON #Opiranserin HCl #UNAFRA Inj

VIVOZON Pharmaceutical's Historic MFDS Approval for UNAFRA Inj.

On February 17, 2025, VIVOZON Pharmaceutical announced a significant milestone in the pharmaceutical industry with the addition of UNAFRA Inj. to its product line. This innovative non-opioid analgesic received approval from the Ministry of Food and Drug Safety (MFDS) in South Korea on December 12, 2024. This development has made UNAFRA Inj. the 38th innovative drug in Korea, marking a turning point in pain management strategies.

UNAFRA Inj. is unique in that it is the first analgesic globally that is both non-opioid and devoid of non-steroidal anti-inflammatory drugs (NSAIDs). It operates by inhibiting specific receptors in the brain and peripheral nervous system, namely Glycine Transporter Type 2 (GlyT2) and Serotonin Receptor 2a (5HT2a). By targeting these dual mechanisms, the drug effectively blocks pain signals, offering dual benefits in pain relief that surpasses conventional treatment options.

Prior to its approval, VIVOZON conducted rigorous clinical trials, demonstrating the drug’s efficacy and safety. A Phase 3 clinical trial in South Korea showed statistically significant results, fulfilling primary endpoints such as the Sum of Pain Intensity Difference over 12 Hours (SPID 12). Furthermore, secondary outcomes confirmed the reduced need for Patient-Controlled Analgesia (PCA) requests and lower opioid consumption within the same timeframe, highlighting its effectiveness in managing pain without the side effects commonly associated with traditional opioid treatments.

The approval of UNAFRA Inj. could significantly alter the landscape for treating moderate to severe pain, especially given the escalating concern over opioid addiction. Medical experts have heralded this analgesic as a 'game changer' in the field, citing rapid pain relief and a reduced risk for patients compared to existing opioid medications, which carry a high potential for dependency.

VIVOZON Pharmaceutical, in its statement, underlined the distinction of UNAFRA Inj. from other domestically launched drugs that typically follow a 'Best-in-Class' or 'Me-Too' approach. Instead, UNAFRA Inj. is being marketed as a