Vivozon said that it has started on a design change for its phase 3b clinical trial to focus on ensuring the significance of the primary endpoint of Opiranserin, its nonnarcotic analgesics.
“It will take more time to prove the possibility of the candidate as a primary treatment,” the company said. “The company plans to enter phase 3 trial for thumb tendonectomy based on the results of a successful phase 2 trial completed in November.”
The company is working on a final protocol and aims to release the topline results by the end of 2020 after enrolling the first patient around April or May, it added.
For abdominal plastic surgery, which failed to meet statistical significance for its primary endpoint during the phase 3a clinical trial at the end of last year, Vivozon will undergo a design change and enroll the first patient around May or June.
“We also plan to release the topline results of the trial in 2020,” the company said. “To do this, Vivozon plans to check the pain intensity of patients who wake up after surgery in the clinic and register only patients with a pain level higher than 4 or 5, while adjusting the amount and type of remedy.”
Through this trial, the company plans to focus on securing significance for a 12-hour pain margin, the primary endpoint that the company failed to meet last time, it said.
Regarding its failure to meet the primary indicator, Vivozon CEO Lee Doo-hyun said, “Opiranserin was administered before anesthesia to reduce the number of narcotic analgesics administered during surgery significantly. However, it did not filter patients who should not have been included in clinical trials.”
The problem was that morphine, which had been administered in limited amounts, almost completely controlled the pain in placebo patients, making it difficult to differentiate between it and Opiranserin’s efficacy, Lee added.
Despite such shortcomings, the company emphasized that it still believed that the treatment is effective.
“Although we did not meet the primary endpoint, the company reconfirmed the superior efficacy of Opiranserin by obtaining statistical significance in all secondary endpoint such as the amount of drug used and the number of requests, the time of the first request for remedy, and the percentage of patients who did not use opioids,” the company said.
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