Vivozon Pharmaceutical said on Thursday that it confirmed the safety and efficacy of its non-narcotic painkiller, Unafra (ingredient: opiranserine) in phase 3 clinical trials in Korea and would seek domestic marketing authorization this year.

Opiranserine (VVZ-149) is an investigational non-narcotic injection-type painkiller that effectively relieves moderate or severe pain. It is intended to be used as a first-line therapy for postoperative pain. 

By simultaneously suppressing the serotonin receptor type 2A and glycine transporter type 2, which transmit pain signals, the multi-target inhibition of these signals in the central and peripheral nervous systems has increased analgesic efficacy and safety, the  Kosdaq-listed company explained. 

VVZ-149 phase 3 clinical trials were conducted in five hospitals -- Seoul National University Hospital, Asan Medical Center, Seoul National University Bundang Hospital, Korea University Anam Hospital, and Samsung Medical Center. 

The evaluation of the efficacy and safety of VVZ-149 was conducted on 285 patients in a randomized, double-blind, placebo-controlled trial.

In phase 3 clinical trials, the time-weighted summed pain intensity difference to baseline over 12 hours (SPID 12) was the primary endpoint to evaluate the analgesic effect of the VVZ-149 injection. Accordingly, the VVZ-149 group showed an average 35 percent higher pain reduction compared to the placebo group, and a statistically significant difference was confirmed with a p-value of 0.0047.

Narcotic painkillers which are administered to patients with severe pain such as postoperative pain and neuropathic pain, are highly addictive, and the death toll from misuse is increasing rapidly, but there is no alternative, so unmet medical demand is very high. 

According to the Ministry of Food and Drug Safety, fentanyl prescriptions increased by 67 percent over the past three years from 891,000 in 2018 to 1.488 million in 2020.

Consequently, the global non-narcotic painkiller market is expected to reach 100 trillion won (approximately $79 billion) by 2030, Vivozon said.

"Based on the successful clinical results of VVZ-149, we plan to apply for an item license in the first half of this year, with the aim to completely replace narcotic painkillers as a postoperative analgesic, said a company official.

As of 11 a.m. on Wednesday, Vivozon Pharmaceutical shares shot up by a daily limit of 30 percent to 1,475 won ($1.17).