VIVOZON Pharmaceutical's UNAFRA Inj. Receives Approval as a Revolutionary Non-Opioid Pain Reliever

VIVOZON Pharmaceutical's Major Milestone: Approval of UNAFRA Inj.

On February 17, 2025, VIVOZON Pharmaceutical announced an important update in the pharmaceutical landscape: the approval of their innovative non-opioid analgesic, UNAFRA Inj. This significant milestone, granted by the Ministry of Food and Drug Safety (MFDS) of South Korea on December 12, 2024, marks UNAFRA Inj. as the 38th innovative drug approved in the region.

What is UNAFRA Inj.?

UNAFRA Inj. is a cutting-edge pain relief medication that operates distinctly from traditional opioid and NSAID painkillers. The drug's active ingredient, Opiranserin HCl, works by simultaneously inhibiting both the glycine transporter type 2 (GlyT2) and the serotonin receptor 2A (5HT2A), thereby blocking pain signals in a synergistic way across the central and peripheral nervous systems. This innovative mechanism positions UNAFRA Inj. as the world’s first non-opioid non-NSAID analgesic.

Clinical Trials Show Promise

Prior to its approval, the safety and efficacy of UNAFRA Inj. were validated through a rigorous Phase 3 clinical trial conducted in South Korea. Notably, the trial met significant statistical benchmarks, confirming its effectiveness in reducing pain intensity over a 12-hour period (measured by the sum of pain intensity difference, SPID 12). Additionally, secondary measurement criteria indicated favorable outcomes in patient-controlled analgesia requests and reduced opioid usage within the same time frame.

A Breakthrough for Pain Management

The approval of UNAFRA Inj. is seen as a watershed moment in addressing moderate to severe pain, particularly in a market where demand for non-opioid solutions has been unmet. Medical professionals have praised the drug for its rapid pain relief capabilities alongside minimal side effects, zero addiction risk compared to existing opioids, and its unique position as the first-in-class medication. Unlike other previously launched drugs in South Korea, which mostly followed the “Best-in-Class” formula, UNAFRA Inj. stands out as a genuine innovation.

VIVOZON Pharmaceutical expressed immense pride and enthusiasm regarding this approval, noting its potential to reshape pain management strategies. A spokesperson emphasized, “We are thrilled to share this revolutionary approval with our stakeholders who have supported us throughout the years. This achievement will accelerate our product launch and marketing efforts.”

Looking Ahead

As VIVOZON Pharmaceutical prepares for the next steps after receiving approval, the pharmaceutical community and patients alike eagerly anticipate the availability of UNAFRA Inj. in the medical market. By addressing significant medical needs with a novel class of analgesic, VIVOZON is not only setting a new standard in pain management but is also paving the way for more innovative approaches in future drug development.