Kyoto University Develops Powerful Non-Opioid Painkiller to Combat Addiction Crisis

FOR IMMEDIATE RELEASE

Groundbreaking Non-Opioid Painkiller ADRIANA Offers Hope in Fighting Opioid Dependence

KYOTO, Japan — In a significant breakthrough that could reshape pain management worldwide, researchers from Kyoto University have developed a powerful new non-opioid analgesic named ADRIANA. This novel drug promises to deliver effective pain relief without the risks of addiction, respiratory depression, and overdose associated with traditional opioids like morphine and fentanyl.

The development comes amid a devastating public health emergency in the United States, where opioid overdoses claimed over 80,000 lives in 2023. ADRIANA represents a pivotal step toward providing clinicians with a safe and effective alternative for treating severe pain.

ADRIANA works through a unique mechanism of action, fundamentally different from that of opioids. The research team was inspired by the body's natural pain-suppression system involving noradrenaline.

"We hypothesized that selectively blocking α2B-adrenoceptors could elevate natural noradrenaline levels, leading to activation of pain-relieving α2A-adrenoceptors without causing cardiovascular instability," explained corresponding author Professor Masatoshi Hagiwara of Kyoto University.

Using a novel screening technology called the TGFα shedding assay, the team discovered the world's first selective α2B-adrenoceptor antagonist. After successful non-clinical studies in mice, the drug progressed to physician-led clinical trials at Kyoto University Hospital.

The results have been highly promising. Both the Phase I trial in healthy volunteers and the Phase II trial in patients with post-operative pain following lung cancer surgery demonstrated strong safety and efficacy profiles.

Building on this success, preparations are now underway for a large-scale Phase II clinical trial in the United States. This international effort is being conducted in collaboration with BTB Therapeutics, Inc., a venture company originating from Kyoto University.

"If successfully commercialized, ADRIANA would offer a new pain management option that does not rely on opioids, contributing significantly to the reduction of opioid use in clinical settings," said Professor Hagiwara.

As Japan's first non-opioid analgesic of its kind, ADRIANA has the potential not only to relieve severe and chronic pain for patients globally but also to play a meaningful role in curbing the opioid crisis.

"We aim to evaluate the analgesic effects of ADRIANA across various types of pain and ultimately make this treatment accessible to a broader population of patients suffering from chronic pain," Hagiwara added.

About the Research:
The development of ADRIANA is led by researchers at Kyoto University. The drug is a first-in-class, selective α2B-adrenoceptor antagonist discovered using a proprietary screening assay. With initial clinical trials in Japan completed successfully, the drug candidate is now advancing to larger trials in the U.S.