The State of the Opioid Epidemic

ACT: What is the current state of the opioid epidemic? What do you think industry needs to do better to progress the use of greater safety standards in developing opioids?

Greg Sturmer: When we look at today's opioid crisis there are two groups that are suffering. You've got patients dealing with moderate to severe pain, and then you have those with opioid use disorder. And they're struggling with abuse. So on the one hand, there's this significant under treatment of pain that's happening worldwide and just not here in the US. In the US pain is not adequately managed for about 80% of patients. And the sad part about it is it's not only undertreated pain, there are consequences to that undertreated pain. And those can include morbidity, functional quality of life, higher health care costs, and it could develop into chronic pain. Then outside the US, you have 150 countries that restrict opioid use, because quite frankly, they have fears based on what has happened here in the United States; these inherent risks of existing opioids that created this opioid crisis. But the reality is the CDC, the Center for Disease Control, they recognize the importance of opioids. And they play an important role in treating moderate to severe pain, because there's certain pain for which non-opioid analgesics just aren't effective. So that's what's happening on the patient side of things. Then on the other side, you have the issues associated with abuse. And these are inherent risks within opioids that create this risk of abuse. Prescription opioids are a gateway to illicit opioids like heroin and fentanyl. And of course, we know that fentanyl is just having a devastating effect on our country right now. What may not be well understood, is that over 90% of the abuse of prescription acute use opioids is via the oral route. So, I think often people think abusing opioids, that means somebody's injecting or inhaling them. 90% of the time, it's simply simultaneously swallowing more pills than is recommended. So, what does that result in? We've got 16 million people worldwide suffering from opioid use disorder, over 9 million in the United States. And so there's been this effort to kind of control to reduce the number of opioids prescribed to try to get control over these numbers. But despite a 44% drop in opioid prescribing, deaths from prescription opioids remains unchanged. It's still at 17,000, which is five times the number that occurred in 1999. And sadly, in the US, there are now over 80,000 deaths from opioids. And that's primarily driven by illicit fentanyl; that's nine people per hour. To put this in perspective, the 80,000 deaths, that's equivalent to a Boeing 700 or 737 airplane crashing every day. Could you imagine if that were the headline? That's what's going on with fentanyl in our country.

Now, your second question was about the industry. What do we think the industry needs to do better to progress towards greater safety standards? Well, I guess what we'd like to do is draw a comparison to the auto industry, because we believe that our pharmaceutical industry needs to take a page out of what's been done in the automobile industry. So, when you look at the history of the automobile industry, they were faced with high fatalities from the use of their products. And they address this issue by making their products safer, rather than removing them from the market. And cars provide unmatched efficiency for transportation. And until the manufacturers incorporated meaningful safety features, they didn't see a decline in fatalities. So, it was all about safety of the product that's on the market. So, like the efficiency of cars, prescription opioids remain the most effective treatment for pain. You know, if you were to talk to an emergency room doctor, and he would say, “I can't do my job unless I have opioids that I can prescribe.” But unlike the auto industry, pharmaceutical companies have never been required to improve opioid safety. And we think that's the change that needs to occur.

We at Elysium have innovated the first “airbags” to reduce suffering from pain, opioid use disorder, and fatal opioid overdoses. Our vision is that the pharmaceutical industry, like the auto industry, we will be required to improve safety of their products by a date certain; no different than what happens in the automobile industry, some new technology comes up and they said, “Okay, all automobiles sold after such and such a date must have ABS brakes." Right? We think the same needs to be done here.

I know that the focus of today's discussion is on the opioid pain aspect of the opioid crisis, but I do think it's important to mention that we're also working on the fentanyl crisis as well. We have a program we call SOOPR, synthetic opioid overdose prevention and rescue, and that represents the first rescue agent specifically designed to combat oral fentanyl and other synthetic opioid overdose. The key there is oral because the oral use of fentanyl creates a much longer duration of action of fentanyl, as opposed to IV use. And we're creating a tool that first responders can use and friends and families can have to have the confidence that they can rescue somebody from a fentanyl overdose.