Video Transcript
Aviva Olsavsky:
So, what do you think about what's in the pipeline in terms of other treatments that are coming into the...
Camille Hoffman:
Yeah, well, I know you know more about this than I do; but a couple of years ago, the FDA approved brexanolone as an IV-administered, 60-hour infusion, with a pretty dramatic response to almost erasing postpartum depression symptomatology. And I think the data are out to 30 days or six weeks, something like that, still with a significant impact.
We've talked before about some of the barriers to that; just the set, and setting, and cost being one of them. And one of the reasons why I’ve still tried—unsuccessfully so far—at getting it at the University of Colorado, but tried, is because depression, and an impaired mama in this time period, is so much different than how a child changes at age 4 or 6. During the first six months postpartum, they just transform from this nearly inanimate little newborn to a developing child and individual. And so, you're the child psychiatrist, so you understand more how that impacts the child; and we know that it does. But I also just feel so much kind of heartache for the mom who misses that because she is so impaired with depression that it all just kind of becomes this blended memory that isn't very pleasant.
So, I'm always talking to patients about, "Hey, if we're going to start you on treatment, this is the goal; that you're doing well, you’re euthymic postpartum, even if that means we need to go up on your dosing before pregnancy, or we start you on meds right after if you have a history and know, so we can really try and prevent you from spiraling down and missing all of this."
Aviva Olsavsky:
Right, and I think your point's really well taken. And I think Bowlby would see you your 6-month sensitive period and raise you to 18 months, because I think really this is such a crucial time in the development of the parent, the baby, and the parent-baby unit. Because when I teach about this, I always say there are three patients in the room, in a way. Yeah, so I think it's really important that we think about how do we take care of people having babies and that baby together.
So often—even say with brexanolone—one of the barriers for people sometimes, if they don't have someone to care for their baby and you're going to do a 60-hour infusion, it's something that we need to think about. What are the resources?
And I think because our society is less resourced for people, and kind of doesn’t really have the same supports, that it might, it's hard for somebody to access that, even if it were possible cost wise, right? And so I think that's a really important thing to consider, because we have to take care of people and we take care of people regardless of what their situation is. And a lot of people don't have partners and so, we have to think about that and how they can have access to the same treatment. So yeah, so I do think there are barriers to that; but I hope that some of those barriers will be navigated. Yeah, so.
Camille Hoffman:
Yeah, in an ideal state–I would love to see just how brexanolone could play out in an ideal state. You identify somebody that's eligible, you're able to bring them in for the infusion—and the medication costs and that kind of organization aside—having a place for the newborn or the infant, and see how much time actually we can gain back by recovering somebody rapidly, and how long that’s sustained.
And I hope that someday those data will be published, too, in order to gain more support for brexanolone. Because I think one of the challenges is that they don't have data out for that long. If they could demonstrate really long-term data and then, "Okay, well, this is how much this event costs, but it's sustained for a year, it's sustained for 18 months," then it's completely worth it. That becomes much more cost effective. And that may be the truth, we just don't know yet.
And I know that there is an oral form. I don't know—it's of brexanolone—I don't know its name. But I think in OB, we're all optimistic that that would have similar efficacy—maybe not as strong. But even if it had 75%, 80% the efficacy of the 60-hour IV infusion, it would absolutely be worth it. Because I suspect that it would be easier to access—slightly less costly. Would really challenge this question of, "Does an admission to a center where you're also able to sleep and receive an infusion in a peaceful, tranquil environment; does that also contribute to the effect?" But the trials were placebo controlled, you can see an effect of that. But still, it becomes significantly more effective with treatment than placebo, kind of controlling for that, sleep, time away from infant and other family members or support.
I'm always optimistic when I see something new, primarily because of how important this time period is, and the transitions that occur during this period that are unlike no other in the lifespan—especially for the baby. But I've seen some recent studies on the use of ketamine. All of the studies that I've been able to see—that were randomized trials—were in other countries, and the ketamine was administered at the time of cesarean delivery.
And in one of the studies, women received general anesthesia for cesarean delivery, so that would be very different than the practice in this country. But it looks like there is a positive impact of ketamine received in a pretty high dose at the time of cesarean delivery on reducing depressive symptoms; where I was a little more disappointed is, the effect is pretty transient.
Some studies it was a matter of days, up to a couple of weeks. But I still wonder if administered by an anesthesiologist— who are very familiar with medications like ketamine—or a psychiatrist in tandem with the anesthesia team, something like that, if that still might be something worth studying to give people a head start. A boost as they're waiting for the efficacy of an SSRI or an SNRI to kick in.
Aviva Olsavsky:
Yeah, it seems like something that requires future study, and I think probably is best looked at in a hospital setting.
Camille Hoffman: Yeah.
Aviva Olsavsky:
Right? For the safety. Yeah, I think that sounds like it really, it should be studied more.
Camille Hoffman:
Well, and I think that in the hands of anesthesiologist, I'd be interested to query. Maybe they’re already using it more frequently than we realize, just for anesthetic use during cesareans. So I’m going to stay tuned to that.
A lot of things to stay tuned to because I remain desperate to have some kind of more rapid treatment for this than what we have now apart from brexanolone, which hopefully will either become more available for more populations as it's around longer, there's more experience, and it's a little bit less complicated by admissions, and the monitoring, and the things that the FDA requires of a new medication like this. But also that an oral formulation, or some easier formulation that isn't as costly, will also become available.