Vivozon, a local biopharmaceutical company, said Friday that it has completed its U.S. phase 3 clinical trial for Opiranserin, a nonnarcotic analgesics, in treating abdominal plastic surgery patients.
“The clinical trial, which started on May 23 and ended on Aug. 19, was participated in by 307 patients,” the company said. “The trial saw no serious or unforeseen side effects.”
The company also completed the U.S. phase 2b clinical trial for Opiranserin on Thursday to treat 60 patients who underwent thumb tendonectomy and plans to finalize the data for both tests by November and release topline clinical results by the end of this year.
“The last four phases 2 clinical trials have demonstrated excellent safety and analgesic effect while reducing opioid use,” the company said. “Opiranserin also showed better analgesic efficacy than opioids for severe pain with pain intensity above seven.”
Vivozon CEO Lee Doo-hyun also said, “Unlike the previous phase 2 clinical trials, the phase 3 and 2b clinical trial were able to limit the use of opioid significantly as the company supported the surgery cost for patients.
The research also showed that the average amount of opioid used was meager, which may directly confirm the unique analgesic effect of Opiranserin, he added.
Lee also noted that the company would step up efforts for technology transfer once the topline results are available.