Vivozon Inc. Tuesday announced that safety and effectiveness endpoints were met with statistical significance in its latest phase 2b trial of non-opioid painkiller opiranserin (VVZ-149) designed to replace narcotic analgesics that can become addictive over time.

The phase 2b study enrolled a total of 60 U.S. patients with pain intensity of four grades or above, eligible for bunionectomy, a surgical procedure to remove a bunion, which is an enlargement of the joint at the base of the big toe. The new painkiller’s safety and tolerability was confirmed through six previous clinical trials.

In the placebo-controlled phase 2b trial ending in August, significant pain reduction was observed within 30 minutes to one hour in the opiranserin group, where about 70 percent of patients pressed the pain-reduction button within 30 minutes and met the pain detection patient percentage proposed by the U.S. Food and Drug Administration, said Vivozon chief executive Lee Doo-hyun. There was a significant difference from the placebo group, meaning opiranserin effectiveness as fast as commonly used narcotic analgesics.

The investigational drug, a glycine transporter 2 (glycine plasma membrane transport protein) and serotonin 2A receptor inhibitor, is a new mechanism-based non-narcotic and non-NSAID analgesic for the treatment of pain and pruritus.

Although statistical significance was not reached in the 12-hour pain margin area, the company said opiranserin confirmed excellent efficacy in patients with pain intensity of seven or above, showing significant differences from the placebo group.

Vivozone aims to win marketing authorization from the FDA in the second half of 2021 and launch the drug in 2022 after its ongoing phase 3 and open-label trials are completed in the U.S.

Vivozone was founded in 2008 and its stock is traded on South Korea’s over-the-counter (OTC) market. The company’s stock price more than quadrupled over the past four months. On Tuesday, the stock price jumped 18 percent to trade at 74,500 won ($64) on the news that the phase 2b trial yielded positive results.

By Moon Ga-young and Minu Kim

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