Vivozon Pharmaceutical(082800) confirmed the possibility of repeat dosing for Korea's first non-narcotic analgesic "Onapra (ingredient name opiranserin)," and is moving in earnest to expand its use. The strategy is to broaden the scope of use, which had been limited to treating acute postoperative pain, to chronic pain to enhance marketability. It will also make another attempt at a U.S. phase 3 trial within the year and speed up efforts to tap the global market.
Vivozon, an affiliate of Vivozon Pharmaceutical, said on the 30th that in an investigator-initiated phase 2 trial conducted by Asan Medical Center, repeated dosing of Onapra at 30-minute intervals led to a statistically significant reduction in pain intensity compared with placebo.
The study was conducted to evaluate analgesic efficacy and safety with repeat dosing in patients with moderate to severe acute postoperative pain. In the area under the curve analysis of pain intensity, the main endpoint, the Onapra group showed significantly lower pain intensity than the placebo group.
These results, as an investigator-initiated study, will not be used directly as regulatory approval data. However, the company sees significance in confirming the possibility of expanding future treatment targets, given that efficacy and safety were observed even with short-interval repeat dosing.
Onapra is the 38th new drug developed in Korea by Vivozon Pharmaceutical. In Dec. 2024, it received product approval from the Ministery of Food and Drug Safety as a treatment to control moderate to severe acute postoperative pain. A phase 3 trial in patients undergoing laparoscopic colectomy demonstrated pain improvement.
The drug is drawing attention as an alternative that can reduce the dependence issues of narcotic analgesics and the gastrointestinal and cardiovascular adverse effects of nonsteroidal anti-inflammatory drugs. It is especially being watched as a potential non-narcotic analgesic that could replace fentanyl.
Earlier this year, an investigator-initiated trial conducted by Seoul Samsung Hospital showed that Onapra produced an analgesic effect similar to fentanyl in postoperative pain management. The results also indicated that when used with other non-narcotic analgesics such as anti-inflammatory drugs, it may be possible to manage postoperative pain without opioids.
Opioids are narcotic analgesics that include morphine, heroin, methadone, fentanyl, and oxycodone. They are widely used for postoperative pain control, but carry high risks of dependence and overdose. In the United States, opioid overdoses became so serious that they were cited as one of the leading causes of death among those ages 25–54, leading to the social problem known as the "Opioid Crisis."
Based on these findings, Vivozon plans to push into the chronic pain treatment field. Until now, Onapra has been used only as a treatment for acute postoperative pain and could not be used for patients with chronic low back pain or neuralgia. The company expects that, because Onapra works by inhibiting pain signal transmission, repeat dosing could allow its use in chronic pain treatment as well.
The company expects that expanding its use will also help boost sales. Onapra, launched as a non-reimbursed drug in October last year, generated 2.9 billion won in sales in just two months. In Korea, it formed a sales and marketing partnership with Korea Daiichi Sankyo for large general hospitals with 300 or more beds, and with Hanmi Pharmaceutical(128940) for medical institutions with fewer than 300 beds.
It will also renew efforts to enter overseas markets. Vivozon Pharmaceutical conducted a phase 3 trial of Onapra in the United States in the late 2010s but failed to achieve statistical significance. The company plans to resubmit an investigational new drug (IND) application for a phase 3 trial to the U.S. Food and Drug Administration (FDA) within the year and pursue a technology transfer deal in parallel.
A Vivozon Pharmaceutical official said, "The domestic phase 3 was conducted in patients with pain after laparoscopic colectomy, but in the United States, it will be conducted in patients with pain after hallux valgus surgery," and added, "We are currently consulting with the FDA on specific clinical designs, including patient group selection."
Next-generation pipeline development is also underway. The oral non-narcotic analgesic candidate "VVZ-2471" was developed based on the platform technology that discovered Onapra, and a phase 2 trial is underway in patients with postherpetic neuralgia (PHN).
Vivozon Pharmaceutical is also pursuing next-generation pipeline development in parallel. The oral non-narcotic analgesic candidate "VVZ-2471" was developed based on the platform technology that discovered Onapra, and a phase 2 trial is underway in patients with postherpetic neuralgia (PHN).
The company is developing VVZ-2471 not only for chronic neuropathic pain but also as a treatment for substance use disorders. Last year, it was selected for a project to develop an opioid use disorder (OUD) therapy by the National Institute on Drug Abuse (NIDA) under the National Institutes of Health (NIH), and it has also applied to the NIH for a cocaine use disorder (CUD) therapy development project and is awaiting the outcome. To date, no drug has been approved as a treatment for cocaine use disorder.