Up to 25% of people experience a euphoric response when taking opioids, a key driver of addiction. The risk is highest for the subset of this group (about 5-6% of the total population) who also have predisposed addictive tendencies. This shows how a prescribed medication can inadvertently lead to addiction in a vulnerable population segment.
To get FDA approval, new opioids must undergo Human Abuse Potential (HAP) studies. In these counter-intuitive trials, the goal is to lose. The drug is tested on recreational opioid users to measure its 'liking' score. Success is defined by demonstrating the new drug is significantly less preferable than existing abusable opioids like Oxycodone.
While traditional opioids target the brain's MOP receptor for pain relief (causing euphoria), the NOP receptor can enhance pain relief while suppressing MOP's addictive side effects. Tris Pharma's new drug is a first-in-class molecule that equally targets both receptors, aiming for effective pain management without the addictive high.
Gaining a broad pain indication requires multiple, distinct clinical trials. Acute pain studies are short-term (e.g., 7 days) and use specific surgical models like bunion removal ('hard tissue') and tummy tucks ('soft tissue'). In contrast, chronic pain trials must run for months and target long-term conditions like diabetic neuropathy or lower back pain.