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FDA Approves New Treatment for Postpartum Depression

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FDA Approves New Treatment for Postpartum Depression

Jun 13, 2019

Postpartum depression is overwhelming depression and the inability to care for yourself and your newborn鈥攁bout 1 in 7 women will suffer from postpartum depression after giving birth. Progesterone is the most common hormone in pregnancy, and the dramatic drop in progesterone after giving birth may have a role in depression postpartum. OB/GYN talks about the pros and cons of brexanolone, a newly FDA-approved synthetic version of the allopregnanolone steroid, meant to treat postpartum depression.

Episode Transcript

This is your brain on hormones. This is your brain off hormones. This is your brain just right. Sounds like Goldilocks? There's a new treatment for postpartum depression that aims to make this better.

About one in seven women will suffer from postpartum depression. This isn't just a couple of days of feeling overwhelmed with the baby blues, something most of us felt in the weeks after a baby is born. This is overwhelming depression and inability to care for oneself and one's newborn. Neuroscientists have always been interested by the effect of sex steroids on the brain, estrogens, progestin, and testosterone. Those of us who practice reproductive endocrinology like me have a particular interest in progesterone and its metabolites, the molecules that the brain makes out of progesterone.

Progesterone and its brain metabolite allopregnanolone seem to make the brain less irritable. And falling progesterone at the end of the menstrual period may have a role in PMS in some vulnerable women. Progesterone is the most abundant hormone in pregnancy and some think that dramatic drop in progesterone after birth may have a role in postpartum depression.

For most women with postpartum depression, it seems to go away in weeks to months, but some women benefit from talk therapy or the usual antidepressants. But that can take weeks for a measurable difference. Until now, the therapies focused on postpartum depression have been based on the same principles and medication as depression that happens to men and women who haven't been recently pregnant. However, looking at the link of falling progesterone and its brain metabolite allopregnanolone, some researchers have wondered if administering allopregnanolone to women with severe postpartum depression who aren't benefiting from regular therapy might be an approach.

A pharmaceutical company has created allopregnanolone in the lab and call it Brexanolone. The research focused on women with severe postpartum depression who are randomized to a 60-hour infusion of Brexanolone or placebo. The women were within six months of giving birth and had experienced depression within a month after delivery. These women were very depressed. Starting out with an average score of 28 out of 30 on a standard depression scale, that's really depressed.

After the infusion, right after the infusion, not weeks later, women who received the Brexanolone had an average score of nine to 10. And women who received placebo had an average score 14. That meant that placebo works which we know from all studies of antidepressants but the Brexanolone worked better. Twice as many women who received the study drug had scores similar to non-depressed women than women who received placebo. The effect lasted for up to 30 days and maybe longer. And this might be enough for other therapies to take hold.

It has some drawbacks. One is that the infusion has to be done in a hospital setting as one in eight women had dizziness and several women temporarily lost consciousness, passed out. The drug itself has an average cost of $34,000 but there may be some ways that insurance or rebates from the drug company might help. And there is the cost of the infusion in the hospital-based monitoring.

The pharmaceutical company is currently studying an oral form of this hormone though they don't call it a hormone. It looks and acts like a naturally occurring hormone allopregnanolone and that's made in the brain, so I call it a hormone.

The most important aspect of those women who had this treatment is that it worked so quickly. We're all concerned that women with postpartum depression get diagnosed, get into treatment, get family support, and get the best therapy. The consequences for the new baby and for the family of a mom who's withdrawn and possibly suicidal is very significant.

So, this therapy isn't necessarily for all women with postpartum depression but for women for whom regular treatment isn't working and who are struggling to care for themselves or their baby. It's an innovative approach and it's good news for the women, their babies, and their families who are struggling at a pivotal time of their lives. So, take care of yourself and your baby. Get help if you need it. There's new stuff on the way. And thanks for joining us on The Scope.