NPR’s Mary-Louise Kelly speaks with Dr. Christina M. Derjanidis, principal investigator of the clinical trial that led to FDA approval of the first home-use oral postnatal depression drug.
Mary Louise Kelly, Host:
The treatment is being called a game changer for a form of depression that affects more than 400,000 people in the United States each year. The FDA has approved the first-ever pill specifically for treating postpartum depression. Now, let’s hear more from Dr. Christina Derigiannidis, the principal investigator of the drug’s clinical trial. Welcome Dr. Derjanidis.
Christina Derjanidis: Thank you.
Kelly: So this pill is called Zranolone? Can you give me a layman’s version of how it works?
Derjanidis: Oh. Zranolone is therefore thought to be a neuroactive steroid that plays a role in stress management deep within the brain. This function is found to be impaired in women who develop depression during pregnancy and postpartum. We suspect it works that way.
Kelly: So how is it different from Prozac and other antidepressants already on the market?
Derjanidis: Not at all. Therefore, as far as we know, these neuroactive steroids do not actually act on serotonin in the brain. So I think the other drugs you mentioned work in a very different way of increasing serotonin, which is why they take so long to take effect.
Kelly: I think that’s one of the promising things here. The women in your trial reported feeling better and having some of their symptoms of depression reduced, and this happened almost immediately. Please tell me more.
Derjanidis: Oh. So a clinical trial tested her single 14-day oral course of zranolone. This was taken by a woman in her home. And they reported rapid antidepressant effects over 14 days and as early as after two doses, namely day 3. And it kept getting better. and followed them all the way to the 45th day. And what we saw was that many women continued to improve.
Kelly: Any side effects?
Derjanidis: Side effects were mild to moderate, mainly drowsiness, dizziness, diarrhea, and fatigue. But you know, it’s a short-term medication treatment. My hope is, therefore, that the discomfort a patient may experience from the drug is of limited duration.
Kelly: Could you clarify if suicidal ideation is a side effect?
Derjanidis: Yes, the zranolone study did not show an increase in reports of suicidal ideation or suicidal behavior. Because it’s an antidepressant, the FDA puts a suicidal ideation risk label on all antidepressants, regardless of whether they found anything in the trials.
Kelly: You know, you said this was designed to be taken for 14 days. I became a new mom. I can say with authority that things aren’t going back to normal for him anytime soon after 14 days. What happens after that?
Derjanidis: Well, this drug really rewires the brain again. And there are preclinical studies showing that it can switch the brain to a healthier state. you’re right. The postpartum period is a very difficult and challenging time for new parents. Other arrangements are possible if additional treatment is required after day 14. You can also use things like talk therapy.
Kelly: A version of this drug is already on the market. Hospitalization for 3 days is required. This is a supervised intravenous treatment. And the price for intravenous therapy was his $34,000, I read. What is the price of this pill?
Mr. Derjanidis: It takes time to understand the insurance coverage of a drug once it is on the market. So we are eagerly awaiting, but we will have to wait a while before we find out what the course of treatment will cost and how insurance companies will cover this new drug.
Kelly: Doctor, what do you think about why it took so long? I imagine postpartum depression has been around for as long as there have been new mothers, since the beginning of the human race.
Derjanidis: It really is. And I think this is another health condition that women suffer from that is just not well researched. That’s why we do the work. However, this is only the second FDA-approved antidepressant for this condition.
Kelly: Christina Derjanidis is a professor in the Behavioral Sciences Laboratory at the Feinstein Institute for Medical Research. Thank you very much.
Derjanidis: Thank you.
Kelly: If you or someone you know may be having suicidal thoughts or is in danger, please call or text the 988 Suicide and Crisis Lifeline, 3 digit 988 .
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