Vivozon applies for preliminary review for non-narcotic painkiller

Vivozon Pharmaceutical said it has applied for a preliminary review of the Ministry of Food and Drug Safety (MFDS) to approve Unafra (opiranserine), a non-narcotic painkiller.

Unafra is an investigational non-narcotic injection-type pain reliever that mitigates moderate or severe pain. It is intended for use 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.

A preliminary review is a formal process in which the MFDS reviews the adequacy of the data required for a new drug license in advance.

The company has applied for the preliminary review of data on the safety and efficacy of the treatment and data on standards and test methods, the most critical data for drug approval.

"Since there has never been a case of a new non-narcotic painkiller approved in Korea, we decided to officially proceed with the preliminary review in discussion with the MFDS," a company official said. "Utilizing the preliminary review system has the advantage of increasing the completeness of the data and responding to the supplementation of the data in advance, shortening the processing period at the approval stage."

The preliminary review submission follows Vivozon’s announcement of phase 3 clinical trials in February.

In the trial, the time-weighted summed pain intensity difference to baseline over 12 hours (SPID 12) for Unafra, the primary endpoint to evaluate the analgesic effect of the VVZ-149 injection, 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.