Clinical trial leader on first FDA-approved pill for postpartum depression

MARY LOUISE KELLY, HOST:

It's being called a game changer for treating a form of depression that impacts more than 400,000 people in the U.S every year. The FDA has just approved the first-ever pill specifically designed to treat postpartum depression. Well, let's hear more from Dr. Kristina Deligiannidis, the principal investigator on the clinical trial for the drug. Dr. Deligiannidis, welcome.

KRISTINA DELIGIANNIDIS: Thank you so much.

KELLY: So this pill is called zuranolone. Give us the layman's version of how it works.

DELIGIANNIDIS: Yeah. So zuranolone is a neuroactive steroid, and we believe that it's helping with stress management deep in the brain. We know that this is dysfunctional during pregnancy and postpartum for women who develop depression then. We think that that might be how it's working.

KELLY: So how different is it from Prozac or other antidepressants already out there?

DELIGIANNIDIS: Completely different. So these neuroactive steroids really, as far as we know, don't work on serotonin in the brain. And so the other medications you noted work in a very different way by increasing serotonin, which I think is why they take quite some time to work.

KELLY: And that's one of the promising things here, I gather. Women participating in your trial reported that they felt better, they felt relief from some of their symptoms of depression, also that this happened fast. Tell me more.

DELIGIANNIDIS: Yeah. So in the clinical trials, we tested a single 14-day oral course of zuranolone. So this was taken at home by women. And they reported rapid antidepressant effects across the 14 days and as early as after two doses, so at day three. And then they continued to improve. And then we followed them all the way out to day 45. And what we saw is that improvement was sustained for many women.

KELLY: Side effects?

DELIGIANNIDIS: Side effects were mild to moderate and were mainly sleepiness, dizziness, diarrhea and fatigue. But it is, you know, a short course of medication. So my hope is that any discomforts patients may have with the medication will be time-limited.

KELLY: Can you clarify whether thoughts of suicide are a side effect?

DELIGIANNIDIS: Yeah, we did not see any increased report of suicidal ideation or suicidal behaviors in any of the zuranolone studies. Because this is an antidepressant, the FDA does have labeling around the risk of suicidal ideation for all antidepressants, unrelated to if they saw anything in the trials.

KELLY: You know, you mentioned this is designed to be taken for 14 days. I have been a new mom. I can state with authority that things don't just snap back to normal after 14 days. What happens after that?

DELIGIANNIDIS: Well, this medication is really, again, rewiring the brain. And so we have research from preclinical studies that show that it's able to switch the brain into a healthier state. You're right. Postpartum time is very difficult, challenging time for new parents. And if they do need additional treatments after day 14, then we have other things. We can, you know, use talk therapies and such.

KELLY: A version of this drug is already out there on the market. It requires being hospitalized for three days. This is supervised intravenous treatment. And the intravenous treatment was priced at $34,000, I read. How much is this pill going to cost?

DELIGIANNIDIS: It takes time for us to even understand the insurance coverage of medications once they're released. So we're eagerly awaiting, though we will have to wait some time to find out the cost of the treatment course and then also how insurers will cover this new medication.

KELLY: What's your take, doctor, on why this has taken so long? Postpartum depression has been around, I imagine, for as long as there have been new mothers, i.e. since the very beginning of humankind.

DELIGIANNIDIS: It really has. And I think that this is just another health condition that women suffer from that's been understudied. So we're doing that work. But it's only the second antidepressant for FDA approval for this condition.

KELLY: Kristina Deligiannidis is a professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research. Thank you so much.

DELIGIANNIDIS: Thank you so much.

KELLY: If you or someone you know may be considering suicide or is in crisis, you can call or text the 988 Suicide and Crisis Lifeline - just those three digits, 988. Transcript provided by NPR, Copyright NPR.