[Asia Economy Reporter Lee Chun-hee] VIVOZON is resuming the Phase 3 clinical trial of the non-opioid analgesic 'Opiranzerin' in the United States.
On the 24th, VIVOZON announced that it will resume the ongoing Phase 3b clinical trial in the U.S. of the non-opioid analgesic Opiranzerin (VVZ-149) injection 'Onapra' for patients undergoing surgery for hallux valgus (bunion). This clinical trial is planned to be conducted with a total of 300 patients.
The trial was originally scheduled to begin early last year but was temporarily suspended due to the COVID-19 pandemic. Although the Delta variant is still spreading, considering the increasing vaccination rate and the strong desire to return to normal life in the U.S., the decision was made to resume the trial.
Opiranzerin previously underwent a Phase 2b clinical trial in the U.S. in November 2019 involving 60 patients with hallux valgus. A VIVOZON official stated, "At that time, due to the insufficient number of patients, statistical significance was not reached in the primary efficacy endpoint, the 12-hour pain area under the curve," adding, "We confirmed that with a sufficient number of subjects, a statistically significant difference could be achieved." Most subjects reported pain relief within 30 minutes to 1 hour after administration, resulting in a significant difference in the percentage of patients experiencing analgesia among the 60 participants.
Lee Doo-hyun, Chairman of VIVOZON, said, "Although the situation is not perfect, the minimum conditions to resume clinical trials have been established, and based on our experience so far, we will pursue a somewhat aggressive clinical progression," adding, "We will complete patient enrollment by early January next year at the latest and accelerate efforts to obtain topline results within the first quarter."
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