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Designing Clinical Studies in Pain Management

ACT: What should industry be keeping top of mind when it comes to designing and executing pain clinical trials?

Greg Sturmer: I guess the first part is kind of, regardless of whether it’s pain, or another indication is what’s always of utmost importance is to keep the end in mind. And the end in this case is, what do I want in my product label? What’s going to be in that label? Because the information that’s in the label is what the company is going to be able to use to market that product. So, what the focus should be on is: how are we going to differentiate our product from what else is out there? So, I mean, the Nirvana is: I’m going to improve on safety, and have a very specific set of clinical studies that support that I’ve got a product that’s much safer than what’s out on the market. And/or I suppose, efficacy, I can set myself apart from the competition, because I’ve got a more effective medication. So I think designing your studies from a safety perspective that says, “Here is the data that shows that we’re better than the current product that leads in the market space as it applies to us.” That’s why our focus is on what we call SMART products. That acronym stands for safer medicines that alleviate risks and trauma. And our effort is to create smart medicines, in pain, smart medicines for opioid use disorder, and smart rescue agents. When it comes to efficacy when you’re trying to differentiate a product from the market, let’s bring it to the pain space. There’s been a concerted effort over the decades to develop a non-opioid pain reliever that’s as or more effective than opioids. And that’s a high bar, because opioids have unmatched efficacy and are unmatched across a spectrum of causes of pain. So, I would say the important thing to do when designing your clinical study is to go head-to-head with whatever is the standard of care. And in the case of pain, opioids, and demonstrate how are you better.