Vivozon's non-narcotic painkiller Unafra scores nod as Korea's 38th homegrown novel drug

Vivozon Pharmaceutical said Friday that its non-narcotic painkiller, Unafra (ingredient: opiranserine), has received marketing authorization from the Ministry of Food and Drug Safety (MFDS), making it the 38th homegrown new drug in Korea.

Unafra, developed using a multi-target drug discovery platform, is a non-narcotic, non-steroidal painkiller designed for the short-term management of moderate to severe acute pain following surgery in adults. Unlike traditional narcotics or NSAIDs, it works by simultaneously inhibiting glycine transporter 2 (GlyT2) and serotonin 2A receptor (5-HT2A), blocking pain signals in the central and peripheral nervous systems.

The drug's effectiveness was demonstrated in phase 3 clinical trials in Korea, where it showed statistical significance in pain relief.

Vivozon submitted its application to the MFDS in November of last year. Primary endpoints included measuring the sum of pain intensity differences over 12-hour intervals, while secondary endpoints included patient-controlled analgesia requests and consumption of PCA and rescue medication.

"This approval is expected to address the high unmet medical needs in the moderate-to-severe pain management market, where alternatives to narcotic painkillers are scarce," said a Vivozon official. "Unafra has shown rapid pain relief with fewer side effects and no addiction risk compared to narcotics."

Vivozon's stock surged by the daily limit of 30 percent to 11,310 won ($7.89) on Friday morning.