Using Digital Therapeutics with Abuse-Deterrent Pain Medication

The opioid crisis in the United States continues to cause chaos and misery. One of the main hurdles preventing the pharma industry from solving this problem is that pain-management medication is still vitally important. Paul Howe, chief commercial officer at Protega Pharma, spoke with Pharmaceutical Executive about ongoing efforts to prevent misuse of these medications, primarily by developing abuse-deterrent medications.

Pharmaceutical Executive: How important is the need for abuse-deterrent immediate-release opioids?
Paul Howe: This is a societal need that we have. We have an opportunity to really do something special in this space that potentially saves lives over time. Our focus is the only immediate release abuse deterrent technology for an oxycodone.

A lot of people have heard about Oxycontin. It's actually been revised, so it's a pretty good extended-release deterrent today. The issue with Purdue was really driving the dose up extraordinarily high. It was not so much that the product, but they drove the dose up. Oxycontin is the one that's currently marketed in the extended-release space. We're in the immediate release and the chronic space. The CDC recommends immediate release versus extended release because of some of the adverse events, and it changed its guidelines the fourth quarter of 2022.

We've had an influx of growth in our space, and it's really just a shift. It's a very big space, with about 40 million prescriptions. Some of that's moved over from the extended-release to the immediate-release, because that's where the recommendation is for usage of an opioid for moderate to severe pain. Ours is the only abuse-deterrent technology in the immediate release space.

PE: In what ways can this medication help?
Howe: This medication can help cut the risk of the escalation that you see when somebody goes from oral to crushing and snorting, smoking, or injecting. There's obviously a lot of times the escalation is very fast, and unfortunately moves on to fentanyl and heroin. It is a rough road once that starts, and our goal is to mitigate that risk and stop it before it starts.

We have FDA approval for the five,10, 15, 30 milligram doses, The most recent, 10 milligram, has become the number one prescribed dose, because a lot of physicians are titrating patients down from doing multi modal. There's a really great multimodal approach in the pain space right now that's emerging, so they're keeping the doses as low as possible, which is the way it should be.

If you or I were going in for hernia surgery and acute care, the five-milligram dose is probably going to work in most cases. If we're getting knee surgery, which is much more complex, we may need to from five to 10, and then titrate back to five and then off. With acute care, the fives are more prescribed, as expected. If somebody's a little more midterm and/or chronic, then the 10 milligram dose is usually the most important dose to have.