VIVOZON Pharmaceutical Obtains MFDS Approval for UNAFRA Inj.: A Breakthrough Non-Opioid analgesic

SEOUL,South Korea,Feb. 18,2025 -- On February 17,VIVOZON Pharmaceutical announced that its non-opioid analgesic,UNAFRA Inj.,was approved on December 12,2024. (active ingredient: Opiranserin HCl),has received approval from the Ministry of Food and Drug Safety (MFDS). With this milestone,UNAFRA Inj. has become the 38th innovative drug in Korea.

UNAFRA Inj.,discovered by using the company's proprietary multi-target drug development platform,is the world's first non-opioid,non-NSAIDS analgesic. It induces analgesic effect by simultaneously inhibiting Glycine Transporter Type 2 (GlyT2) and Serotonin Receptor 2a (5HT2a),thereby blocking pain signals and transmission synergistically across both the central and peripheral nervous systems.

Previously,VIVOZON Pharmaceutical confirmed the safety and tolerance of the drug and secured statistical significance for efficacy in a domestic Phase 3 clinical trial and applied for new drug application (NDA) from MFDS in November 2023. The efficacy of the drug was confirmed through the primary endpoint Sum of Pain Intensity Difference over 12 Hours (SPID 12),and secondary endpoints including number of Patient-Controlled Analgesia (PCA) requests and opioid consumption over 12 Hours.

This approval marks a breakthrough in the treatment landscape for moderate to severe pain,addressing the high unmet medical needs in a market that previously lacked alternatives to opioid analgesics. UNAFRA Inj. has been hailed as a game changer by the medical community,showing rapid pain relief with fewer side effects and zero risk of addiction compared to existing opioids with severe addiction.

The company emphasized that UNAFRA Inj. stands apart from earlier domestically developed drugs,which were primarily "Best-in-Class" or "Me-Too" drugs mimicking existing treatments. In contrast,UNAFRA Inj. is Korea's first "First-in-Class" innovative new drug,demonstrating significant advancements in drug development complexity and originality.

Spokesperson from the company states,"We are thrilled to share this groundbreaking approval with our shareholders and investors who have supported us over the years. This milestone will accelerate our plans for product launch and marketing activities.