Vivozon Pharmaceutical is preparing to launch Unafra (opiranserin), a novel non-narcotic pain reliever, in the second half of 2025, with ambitions to capture a significant share of the post-surgical pain management market. The company aims to achieve KRW 100 billion (approximately USD 68.9 million) in sales within five years, positioning Unafra as a safer alternative to opioid painkillers like fentanyl and oxycodone.
Regulatory Approval and Clinical Efficacy
Unafra received marketing approval from the Ministry of Food and Drug Safety (MFDS) on December 12, marking a pivotal milestone for Vivozon. This approval followed a Phase 3 clinical trial involving 284 patients recovering from laparoscopic colon resection surgery. The results demonstrated that patients administered Unafra experienced a 35% improvement in pain relief, as measured by the sum of pain intensity differences (SPID 12), compared to the placebo group. The drug also met safety evaluation standards.
Mechanism of Action and Therapeutic Potential
Unafra distinguishes itself as a first-in-class analgesic with a unique dual mechanism of action. It functions by suppressing the glycine transporter type 2 (GlyT2) and serotonin receptor type 2A (5HT2a), both of which play crucial roles in transmitting pain signals within the central and peripheral nervous systems. This innovative approach allows Unafra to effectively alleviate moderate to severe acute pain without the addictive potential associated with narcotic painkillers.
Addressing Unmet Needs in Post-Surgical Pain Management
The MFDS approval of Unafra is specifically for use in adult patients experiencing moderate to severe acute pain after surgery, an area where there is a recognized unmet medical need for non-opioid alternatives. According to Shin hyun chul, Executive Director and head of the new drug marketing division at Vivozon Pharmaceutical, Unafra has the potential to cover all surgical patients experiencing such pain, excluding OB/GYN and pediatric surgeries, which account for approximately 1 million surgeries annually in Korea.
Commercialization Strategy and Global Expansion
Vivozon is currently in discussions with Boryung (formerly Boryung Pharmaceutical) to establish a domestic commercialization partnership for Unafra. The company is also exploring various formulations of Unafra, including oral tablets and transdermal patches, as well as low-dose injections for repeated administrations. Furthermore, Vivozon is planning to initiate Phase 3 clinical trials in the U.S. next year, signaling its commitment to expanding Unafra's global presence and addressing the need for effective non-narcotic pain relief options worldwide.
