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So good, so good, so good.
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D
I think I can sum up the show for you with one word.
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Nothing. Nothing. Nothing. What does that mean?
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D
The show is about nothing.
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Well, it's not about nothing.
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D
No, it's about nothing.
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Well, maybe in philosophy, but even nothing is something. So in the iconic show Seinfeld, in the episode called the Pitch, when Jerry and George are pitching the show Seinfeld to the executives, remember, the show was about nothing. It's a great episode, not a sponsor, but it is loosely related to what we're talking about. Let me set the stage here. I'm recording this on October 10, 2025, and just yesterday, just yesterday, on October 9, 2025, there's a new clinical practice update, a CPU from the college. Now, I knew this was coming out and I was hoping that we'd have some eye opening stuff, but I found this very applicable, that the new clinical practice update, the cpu, and I have no beef with anybody. No beef with anybody. But the new clinical practice update is in true George style, about nothing. Nothing. Hold on a minute before you send me an ugly email before you do that, or a nice, nice, sarcastic little memo on our podcast or on insta. Let me explain why, as George said very, very eloquently on that episode called the Pitch, how the show is about not so this new practice update, which came out on October 9, the title of which is Zuranolone and brexanolone for the treatment of postpartum depression. Honestly, guys, we're called the no Spin podcast because I'm gonna tell you as it is, there is nothing new. Nothing new in this episode. I think it's pretty fascinating. There's nothing new.
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I think I can sum up the show for you with one wor.
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Nothing.
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Nothing, Nothing.
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So here's what I mean by nothing. There's nothing new in this. Because while this is brand new, it's a clinical practice update. And it does replace the practice advisory From August of 2023, which was zuranolone for the treatment of postpartum depression, which was ACOG's response to the FDA then passing zuranolone for postpartum depression as the first FDA approved medication for postpartum depression. Even though. Even though cost was an issue, because while it was not as expensive as its original and sister product, Brexenolone, it's still like 16 grand. You heard right, 16 grand, that's three zeros. Although in all disclosure, Sage Therapeutics does have a patient program where they can get it with reduced cost, but still, like, right off the chute. If you're gonna do this cash, forget about it. I mean, it's like 16 grand. Although, you know, I'm not minimizing the importance of postpartum depression. We gotta do something. But questions remain about Zuranolone to this day. And I'll get into that in this episode. But the original practice advisory from the college titled Zuranolone, which is zirzuve for the treatment of postpartum depression, was released in August of 2023. And now spring forward two years to October 9, 2020, we get zuranolone and brexanolone for the treatment of postpartum depression. This is a clinical practice update. Now, traditionally, a CPU is like, hey, we've got new data X, Y and Z. Looks like it's gonna work pretty well. Or the opposite, it's probably not gonna work very well, like progesterone intramuscular for preterm labor. So when that prolonged trial came out, that was a clinical practice update about that as well as a practice advisory. So my point is, I saw this yesterday in the last 24 hours. I'm like, oh, what's. Wait a minute. I didn't know there was anything new going on. I'm pretty, you know, observant of the data. And what is new about this? And once again, and not being mean to anybody, because this is not personal, I don't have a beef with anybody. But as George once again said, it's about nothing.
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Sum up the show for you with one word, nothing.
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Let me explain. So what this clinical practice update is, is basically a negation of one part of the previous guidance on postpartum depression from the college, because this new clinical practice update does update and remove a couple of things. First of all, it is a new update of clinical practice guidance number 4 5, which is treatment and management of mental health conditions during pregnancy and postpartum. That was in 2023. And as we just stated, this August 2023 practice advisory on zuranolone. So it's a very minor tweak. And so I compared both the original practice advisory from August 2023 and this new clinical practice update from October 9, 2025. And. And it is pretty much a cut and paste deal. Cut and paste deal, meaning there's nothing new. But I did use this opportunity. I thought, you know what, even though there's nothing new, I'm going to explain why they did do a CPU and why that was released because they had to backtrack something regarding Brexenolone. I thought it'd be a good opportunity to just briefly discuss some of the potential. Well, not potential. Some of the real questions that clinicians and other researchers have regarding Zerzuvi Zuranolone, which is. Is this the best we got, guys? Zerzuvi, which I am not minimizing the potential benefit here for postpartum depression, which you can use this medication up to a year postpartum. Right? It's in the first postpartum period, which includes 12 months of delivery. All right, so totally fine. If postpartum depression starts in the third trimester or within the four weeks, this is okay to use or up to or within the first 12 months of delivery. So I'm not minimizing this. This can be standalone or it can be done as an adjuvant to an existing medication that's already on board, like an ssri. But questions remain. Number one, the side effects. This is. This makes you very somnolent, kind of confused, a little bit super drowsy because of how it works as a GABAergic medication. So there's questions about that. Two is the data followed patients to a max of four weeks. Four weeks. So like, hey, how are you doing four weeks after your last tablet? You good? You're good. Success. And I'm not minimizing. That's fantastic. If they take the two week therapy, because this is an oral medication for two weeks and they feel good a month later, that's great. But what about two months later or three months later? So this was the original study which use a Hamilton depression rating scale. They took the medication for two weeks and on the 15th day said, how you doing? And compared the scales. Yeah, and they were better one day after you completed the treatment. Now, the Xerzuvi effect was still shown at day 45, which is four weeks after the last dose of Zerzuvi. But that's all we know. Let me say that again. That is all we know. And nobody knows what to do after that. Do you redose it? Do you just switch to something else? Those are questions that remain. And then the main cost, of course, the main cost, the main question, of course, is cost and its applicability in the general population. Who could actually afford this and who covers this? And there is the potential, guys, I'm gonna say this right now. In the intro, there is the potential that should the patient conceive on this medication, it's. It's kind of worrisome. Okay? So patients are supposed to use effective birth control while they're on this medication through one week after treatment. Okay? So number one, they have to pump and discard so they can't use that breast milk. And there is an issue of the concern of potential embryopathy so that patients cannot use this and get pregnant. So patients need to know that this does transfer, it looks like, into human milk. And so right now the data show that you can't breastfeed, although it's limited data pumping. And discarding the milk through one week after treatment may be the best way to do it, because even though we don't have, you know, real good safety data, it's better to be safe. Okay? So there's questions that remain there. Plus, of course, is the issue that this medication, you know, which seemed to be helpful again, at least in the short term, didn't have any comparison to the usual stuff. Right? It wasn't compared to cognitive behavioral therapy or how it works with the usual medications, the local pharmacotherapy or emdr. So that's a gap here that we just don't know. So I just find it interesting that there's so much of a desire to have a true FDA approved medication for postpartum depression, which is what we need for sure, that it kind of was the Addie issue. Okay, Addie, you remember the Flamanstren for female sexual dysfunctional dysfunction and arousal or desire disorder. And you know, Addie failed when it went up to the FDI multiple times, but there was such an outcry that we want our own FDA approved medication for female sexual dysfunction, primarily for desire disorder, that it passed it, even though the data was terrible. So I'm not saying that the data for Surzuvi was terrible. I'm just saying that it's not the end all be all, definitely not the end all be all for postpartum depression. Although I absolutely welcome, to be very clear, I absolutely welcome any medication for postpartum depression because we have to do more. So that's just the intro, guys. Let me get out of this intro and, and let me just very quickly, when we come back from our lead in, I just want to give you what this Clinical practice update from October 9, 2025 is and what it isn't. We'll be right back. Tired of all the spin in women's health education? Yeah, so are we. This is Dr. Chapa's OB GYN no Spin podcast. Foreign.
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I think I can sum up the show for you with one word.
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Nothing. All right. All right. So let's go back to this new clinical practice update. Clinical practice update from October 9, 2025, a CPU. Let me tell you what, what it is not, it's not anything new, okay? I actually looked at this, compared it to the practice advisory from August 2023. I'm like, what, what is the new part? And it literally is a cut and paste from the August of 2023 into this new one. But really, what this CPU is, and I love it because I got, you know, all this, you know, updates from, you know, these other, you know, medical sides, like, oh, the ACOG has released a new practice advisory on zuranolone and brexanolone for the treatment of postpartum depression. So my first question was, wait, what? Brexanolone. That's not even a thing anymore because nobody could afford, afford that joker. So they pulled it. They pulled it off the market, right? That went off it. Actually, they pulled it like in January of 2025, but in April 2025, it was no longer commercially available. So brexanolone, which was the IV version of zuranolone, and we covered this, guys, remember, we have episodes on this, which is an allopregnanolone derivative. So it's very novel, very novel. And the biology does work. But, but the issue of cost and, and how, like, brexenolone was done because it required a 60 hour IV infusion. No longer available. No longer available. Not available in the US and not available in the uk. I mean, it's just. It's dead and buried. They're like, forget about. Nobody's using that because they had so much pushback. Because it was like 30 grand. Okay? Like 30. And then with three zeros afterwards, insane. Insane. And I'm 100% capitalist, baby. I mean, I sure am. But at some point, you're like 30 grand and 60 hours of an IV infusion. Plus it made them super, you know, kind of sleepy and had some blood pressure effects. So it's gone. It's gone. The same company then launched the oral medication, the sister medication, which is Zuranolone. Not a sponsor. Cerzuve, which is an oral medication for 14 days. Okay, for 14 days. So ACOG, again, remember, ACOG does say, hey, this is something you can consider either as solo therapy or with a regular medication for anything that's considered postpartum depression. And remember that the definition of postpartum depression goes for the first year, the first 12 months from delivery. All right? So that hasn't changed. Everything that it has in this new CPU is exactly what is in the August 2023 one. Nothing is new. What this new clinical practice update does have is a retraction of the part about brexenolone because it had to say something because it's no longer available. So this CPU does say that while ACOG originally recommended brexitolone by IV infusion for moderate to severe perinatal depression, it's now gone. ACOG recommended consideration of brexanolone administration by IV infusion in the postpartum period for moderate to severe perinatal depression with onset in the third trimester or within four weeks postpartum. However, brexenolone is no longer commercially available in the United states as of January 1, 2025. And then the FDA approval was withdrawn April 14, 2025, as requested by the manufacturer. End quote. Okay, so I read that. I'm like, okay, okay, so what else is new? We knew that it's gone. Nobody could afford it. Nobody wanted to do that. What else is new? There's nothing. It does talk about. Zuranolone does talk about the CNS depression effects. So you gotta be careful. Nobody needs to drive after they take this medication. There's a lot of restrictions with this because medication is pretty heavy. I mean, it kind of makes you feel a little wiggy. And so you have to have a lot of restriction for this because it does have this Real CNS depression issues. Not depression like depression as in the mood, but CNS depressant effects, as in terms of somnolence, all right? And a lot of sedation. So if this is tough, remember, these are postpartum women which have a new newborn or at least, you know, a year old. And so this is the issues here, because if they take this, somebody has to watch them. They have to make sure that for 12 hours after each dose, they shouldn't drive, you know, operate heavy machinery or do anything that potentially could put them at risk, quote, including feeding, changing or bathing the child, end quote. Guys, I kid you not, okay? And I have no beef with Sir Zuvi, all right? Or Zuran alone. None. None. So if somebody's listening to this and their grandpa, grandma, sister, neighbor or lover, whatever works for Sage Therapeutics, I got no beef with them. I don't at all. But on the no Spin podcast, I'm gonna tell you the truth in this clinical practice update, which is exactly what's in the manufacturer's guide. Quote. For at least 12 hours after each dose, patients should avoid driving, operating heavy machinery, engaging in potentially dangerous activities, and importantly, caring for their infant alone, including feeding, changing, or bathing. End quote. I'm not. I'm not against Zuranolone, guys. I'm just saying, again, it's very tricky here because it's a tough medication. And remember, you still need to use contraception and for a week after treatment and pump and discard. It's kind of a tough medication and it wasn't even compared to, to the standard stuff that we use like SSRIs or Prozac or whatever. Wellbutrin or behavioral cognitive therapy or things like emdr. All right, so this is why I just think we need to keep going. We need to keep looking. If we think we got the holy grail here for the medication on postpartum depression, it's probably not it. Plus, a big question that remains is what do you do if a patient is it feels good at four weeks after the last pill, but at six weeks starts feeling depressed again and has a horrible scale? Can you retreat them? So the most practical answer would be, well, I guess so. Sure. Just give them another 14 day trial. However, that's off label and that's based on expert opinion because we have no data, we have no regulatory guidance that says that we can do that. Okay, so nobody has published that yet. Maybe they will if retreatment for this for recurrence after the 14 day therapy, if that's effective and what that protocol would look like. So we don't have that.
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So interesting that this clinical practice update from October 9, 2025 really is just a retraction of that. Well, Bruxanolin isn't around anymore. Otherwise. Otherwise, hey, we still have Zirzuvi, so don't forget about it. Even though they can't change the kid by themselves or feed the child by themselves and they get kind of goofy for 12 hours after the last dose. But we got Zirzuvi. The American College of Obstetricians and Gynecologists recommends consideration. So it doesn't recommend it straight, just consideration of serenolone in the Postpartum period within 12 months of delivery for severe depression that has onset in the third trimester or within four weeks. End quote. Now remember, this is supposed to be for moderate to severe. Moderate to severe. This is not for. I'm feeling kind of sad little postpartum blues. This is, this is, this is the shotgun approach to that. However, and I get that if a patient has severe limitation from postpartum depression, then I'm all for it with those limitations that we've already discussed. One of the last things I want to cover, of course, I mean additionally, is that I do hope new medications come for postpartum depression because I don't know if Zuranolone, it's kind of. Again, it's the addie. What Addi is for sexual function is what Zuranolone kind of is for postpartum depression. Long term, because we don't have that data short term. Yes. Their scale at day 15 was better than it was on day one. After two weeks of therapy it was. That's why the FDA passed it. But is that our goal? You feel good one day after you finish your 14 day course or up to a month thereafter, what happens afterwards? We don't have that. And so that's all I'm saying. I'm not mad at anybody. I'm just saying that we probably need more information. By the way, I said all of this when we covered Zoran alone. Zerzuvi's episode when it was first Approved back in 2023. We have an episode of that. If you want to go back and listen to all that, go ahead. By the way, you also have to take this in the evening. With a fatty meal. You can't take it fasting. So all these little limitations or restrictions and. Or guidance that go with this, I just found that interesting that there's. There's really nothing new. There's nothing new in this new CPU from October 9, 2025, except Roxanne alone and gone. Roxanne alone, gone. And that's pretty much where we're at here. Should we do the George thing one more time? Michael, leave it alone. What do you want to do? We're gonna do one more time, and then we're gonna call it a day.
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I think I can sum up the show for you with one word.
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Nothing. Nothing.
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Nothing.
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Oh, my goodness. I think I can sum up this new clinical practice update from October 9, 2025 in one word. Nothing. I don't know. I don't know, guys. I'm sorry. My sense of humor is not for everybody. That's all right. It makes me laugh. And Michael just shakes his head. Podcast family, as always, we're thankful for you. We're glad you're part of our podcast community. And as always, we appreciate all of your support as you've given us throughout the years. And now that we've done all that, before I get into any more trouble, Michael, let's take it home. Podcast family, we're thankful for all of the support that you've given us throughout the years. This has been the OB GYN no Spin podcast. We'll see you on the next episode. Sam.