Vivozon Pharma Begins Preliminary Review for Opiranserin Product Approval with MFDS

Vivozon Pharmaceutical has taken active steps to obtain domestic approval for the non-narcotic analgesic Opiranserin injection (Onapraju).

On the 3rd, Vivozon Pharmaceutical announced that it had completed the documentation required for the approval of Opiranserin injection and submitted a preliminary review request to the Ministry of Food and Drug Safety (MFDS). The preliminary review is an official procedure in which the MFDS reviews the suitability of the data necessary for drug approval in advance. Vivozon Pharmaceutical applied for the preliminary review focusing on the most important data for approval: 'safety and efficacy data' and 'standards and test methods data.'

A company representative stated, “Since there has been no case of a non-narcotic analgesic new drug proceeding to approval domestically, we decided to officially conduct a preliminary review in consultation with the MFDS. Utilizing the preliminary review system improves the completeness of the data and allows us to respond to data supplementation in advance, which shortens the processing time at the approval stage and promotes product commercialization.”

In March, Vivozon Pharmaceutical announced that in the domestic Phase 3 clinical trial of Opiranserin injection, statistical significance was secured in the primary endpoint, ‘12-hour Sum of Pain Intensity Difference (SPID 12),’ and the secondary endpoints, ‘12-hour patient-controlled analgesia (PCA) request count’ and ‘12-hour PCA and rescue medication consumption.’ This confirmed the analgesic efficacy of Opiranserin injection and its effect in reducing the use of narcotic analgesics. The safety and tolerability of Opiranserin injection have been demonstrated in multiple domestic and international clinical trials.

This content was produced with the assistance of AI translation services.