Addressing OUD Treatment Gaps & Improving Patient Outcomes

Fentanyl's presence in the illegal drug supply chain complicates treatment for OUD. How do the findings from this study contribute to addressing these treatment gaps and improving patient outcomes for those struggling with fentanyl dependence?

Given that this was the first time a phase three study of long acting injectable buprenorphine versus sublingual actually evaluated the presence of fentanyl, not only at baseline, but at every opioid assessment throughout the study, it does give more information than we've seen previously from Phase III studies about the impact of buprenorphine, and specifically long acting injectable buprenorphine in the presence of fentanyl, And we did see that in both of the subgroups and in both of the arms in each subgroup, whether it was BRIXADI® or sublingual buprenorphine, we did see reductions in the use of opioids and reduction in the use of fentanyl in those patients in the fentanyl subgroup.

Building on this initial analysis, are there any specific next steps Braeburn is considering for further research on the use of BRIXADI® for patients with OUD who test positive for fentanyl?

We do have an investigator-initiated grant program where we provide BRIXADI® to investigators that are doing their own studies, and we don't impact those study protocols or anything. They come to us, they say, we want to do this study, and we either say, yes, we'll provide BRIXADI®, or no, we can't. And so, we've actually supported several studies through that. In fact, just last week, also in JAMA Network open there was a publication by Dr. D’Onofrio and her colleagues of a study that we supported called ED-INNOVATION.

This was an ancillary sub study 100 patients, 70% of whom did test positive for fentanyl and this has been conducted just in the past couple years. So this is reflective of the current drug supply and they did find that in those patients, they were able to initiate BRIXADI® with patients who came in with very low levels of withdrawal. And you know, currently in our label, it does say that you want to start patients on BRIXADI® when they are in mild to moderate withdrawal. They, in this study, looked at patients, many of whom were on fentanyl, and found that even at lower levels of withdrawal, they could successfully initiate BRIXADI®.

That study, as I said, is a sub study. They have a larger study they're enrolling 2000 patients, 1000 on BRIXADI® and 1000 on sublingual and so we'll see a lot more data from that study coming up properly in the fall. And then there's several other studies that are being conducted now that look at different settings in which patients with opioid use disorder may be treated that will help us better understand the utilization of BRIXADI® in those patients, but also specifically the impact on patients with fentanyl, given that those are the patients that are being enrolled in these studies.

How can Braeburn work to ensure broader patient access to BRIXADI®, particularly for those in underserved communities facing the brunt of the opioid crisis and fentanyl's deadly effects?

Thank you for asking the question, because it is really critical that we keep in mind those who are underserved, especially in this disease state where only one in five people actually receive treatment for opioid use disorder. Men are six times more likely to receive treatment than women. White people are 14 times more likely to receive treatment than black people. I think that there's really a serious issue with underserved populations not getting the care that they need.

In this space, we did see in the last year a little bit of a leveling off of over overdose rates over. All. But if you look in and traditionally marginalized and minoritized communities, we see continued increases in overdose rates within those communities. So, we’ve got to do a better job.

Braeburn has been really committed to this. We really focused on ensuring that there was access to our product under Medicaid, and we've been very pleased to see that in most states, they understand the need as well, and we've been able to obtain good formulary coverage on Medicaid, usually without a prior authorization. Some states, it's been a little bit more challenging, but we continue to work with those states and emphasize the important need for patients with opioid use disorder to be able to access treatment.