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VIVOZON Pharmaceutical's UNAFRA Inj. Approved by MFDS

On February 17, 2025, VIVOZON Pharmaceutical announced its groundbreaking non-opioid analgesic, UNAFRA Inj., has received approval from the Ministry of Food and Drug Safety (MFDS) in South Korea, effective December 12, 2024. This significant milestone marks UNAFRA Inj. as Korea’s 38th innovative drug, highlighting the company’s commitment to advancing pharmaceutical solutions.

What Makes UNAFRA Inj. Stand Out?

Developed using VIVOZON's proprietary Multi-Target Drug Development Platform, UNAFRA Inj. is notable for being the world's first non-opioid, non-NSAID analgesic. Its mechanism functions by simultaneously inhibiting the Glycine Transporter Type 2 (GlyT2) and the Serotonin Receptor 2a (5HT2a). This dual action synergistically blocks pain signals both in the central and peripheral nervous systems, offering a novel approach to pain management.

Clinical Validation

Prior to its approval, the safety and efficacy of UNAFRA Inj. were rigorously tested in a nationwide Phase 3 clinical trial. The results showed statistically significant effectiveness for pain reduction, evaluated using metrics such as the Sum of Pain Intensity Differences over 12 hours (SPID 12). Secondary endpoints included patient-controlled analgesia requests and opioid consumption over the same period, reinforcing the analgesic’s potential as a powerful alternative in treating moderate to severe pain.

Meeting Medical Needs

UNAFRA Inj. addresses a critical gap in the current medical landscape, where there is a pressing need for alternatives to opioid analgesics. The increased prevalence of opioid dependency raises concerns, making UNAFRA Inj. a timely solution to manage pain effectively without the associated risks of addiction and side effects.

The medical community has heralded UNAFRA Inj. as a groundbreaking option, capable of delivering fast pain relief while minimizing adverse effects when compared to existing opioid therapies. This positions the drug not just as another option, but as a transformative advancement in pain relief.

A New Class of Medication

What truly sets UNAFRA Inj. apart is its categorization as Korea’s first “First-in-Class” medication, straying from the traditional “Best-in-Class” or “Me-Too” drugs that simply replicate existing treatments. UNAFRA Inj. signifies a leap in originality and complexity in drug development, making it a standout in the ever-evolving pharmaceutical industry.

A company spokesperson expressed enthusiasm about the approval, stating, "We are excited to share this groundbreaking news with our shareholders and investors who have supported us throughout the years. This milestone will accelerate our plans for product launch and marketing activities."

As the healthcare landscape continues to shift, innovations like UNAFRA Inj. are essential in addressing the needs of patients while mitigating the risks associated with traditional opioid medications. VIVOZON’s commitment to innovative pharmaceutical solutions promises to enhance the quality of pain management therapies available in the market.