Sabrina Johnson: Both great questions. Thanks for asking about that program. Since we’ve initiated the study, we’ve just been so excited about the level of interest in that program that we’re running in Australia. So we’re very much looking forward to the results. And the trial is very much in the dosage forms that we’re studying is very much designed to answer exactly what you’re asking. So first of all, we, of course, did take into consideration what’s delivered with the oral doses of diclofenac and what you see systemically and diclofenac, in particular, has demonstrated benefits in dysmenorrhea, actually not just for the pain but also even sometimes in the heavy bleeding that women can have. So we did look at that. But as you can appreciate, when you’re going from systemic oral delivery to delivering localized, it’s not one to one.
Again, XACIATO is a wonderful example here. We have very low levels of clindamycin systemically. That’s why we were able to get some of the safety labeling we were able to get in XACIATO because of that. that we have very good concentrations of clindamycin locally, right, where you need it. So we’re trying to do the same thing with PDM1. So we selected doses, again, taking into consideration the amount of diclofenac you have systemically but not trying to match those dose levels but trying to think about, therefore, the amounts that we would want to be achieved localized in the localized tissue environment. So that’s how we selected the doses. And to your question on how fast we see effect and duration of effect, similarly, that’s what we’re looking to understand better in this study.
And so the way the study is designed, the women — first of all, women in the study will have the condition. So it’s like it’s healthy normals but they’re healthy normals with dysmenorrhea. So they will have the conditions. So that’s why we’re also able to look at and not powered for efficacy but also be able to look at what effect they may experience with the product and it’s designed to look at both single administration and multiple administration. So it’s going to give us a lot of insight. Again, we know from our XACIATO experience that this formulation stays resident in the vaginal environment. So it’s not just at the time of dosing but beyond that, when you look at both vaginal and systemic PK levels, so we’re expecting to see the same thing.
So I wish I had answers to you today. But what we’re hoping, we know from XACIATO, how the product and how that formulation technology performs. So we took that into consideration as we designed DARE-PDM1. And then the Phase 1 is really designed to answer those exact questions. Like how long does the product stay resident, how long of effective she have after one time of dosing, how long does it say resident and then what happens if we allow her actually to dose multiple times.
Kumaraguru Raja: Great. I just tied to a question on XACIATO. John alluded to this a little bit. So in terms of payer negotiation, what can you guys share with us? And is the expectation that there is going to be some step edits there? Maybe just a little bit of clarity on like where you guys stand there right now.
Sabrina Johnson: Yes, absolutely. So let me say a couple of words and then I’ll turn it over to John in even thing could add. So first of all, I want to clarify one thing because I think it sometimes does get confusing sometimes because you talk about launch, then we talk about first commercial sale. So as John alluded to, activities that you do, right, to that are part of that launch strategy, such as payer interactions those started. Those actually started last year, right? Those activities have been underway. And as you noted, right, very, very important activities. It’s the actual first commercial sale that is being targeted for the second quarter. But those kind of launch activities and launch preparation activities have obviously already been underway.
