Updated: Apr 26, 2019
A New medication to treat postpartum depression could be entering the US market soon.
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The postpartum period is a high-risk time for developing depression and suicidal thoughts. Untreated postpartum depression adversely affects not only the woman, but often her baby, her partner and her extended family. For these reasons, there’s a compelling need for effective treatments for postpartum depression.
Just recently, the FDA approved the first-ever treatment specifically for postpartum depression. It’s a medication called brexanolone, marketed under the brand name Zulresso©. It’s administered by a continuous intravenous infusion over the course of 60 hours. It’s gotten considerable media coverage, so Veterans may ask you about it.
Here are some relevant facts:
· Initial studies show it’s more effective than placebo for treating postpartum depression.
· When it works, it works quickly.
· So far it’s been studied on a relatively small number of women.
· No longer-term follow-up studies are available yet. It’s not clear how long the improvement lasts.
· It’s likely to be pricey; estimates range from $20,000 - $35,000 per treatment.
· It can be challenging for a new mom to spend 60 hours getting an infusion under sedation.
· Its side effect profile isn’t fully understood yet. A key safety concern is that some women enrolled in the studies lost consciousness during the infusions. For this reason, a Risk Evaluation and Mitigation Strategy (REMS) will be required.
· Like all medications, it will be present in breast milk. Effects on breastfeeding babies haven’t yet been studied.
There is strong evidence for the efficacy of the following treatments for postpartum depression:
· Interpersonal psychotherapy
· Cognitive-behavioral psychotherapy
· Antidepressant medications
Brexanolone is not yet on the market in the U.S. It’s expected to become available within a few months. Once it becomes available in the U.S., it will be a non-formulary medication pending Pharmacy Benefit Management review. Until a national formulary decision is made, each VA facility can make a local decision about the use of this agent. Any facility deciding to use brexanolone will need systems in place to comply with REMS requirements. A description of REMS requirements can be found at this link: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=387
More detailed background (neurophysiologic rationale for this medication)
The hormone progesterone is metabolized in the brain to allopregnanolone (ALLO). ALLO is what’s called a neuroactive steroid, meaning that it acts rapidly on the brain to influence neurotransmission. ALLO is a natural calming agent because it activates a “mellowing” (inhibitory) neurotransmitter called gamma-amino butyric acid (GABA). ALLO levels rise considerably during pregnancy due to increased progesterone, then fall abruptly and dramatically postpartum. GABA receptors down-regulate and up-regulate to compensate for these changes (meaning the number and density of receptors goes down during pregnancy and up postpartum). It’s posited (but not proven) that some women’s brains can’t up-regulate as quickly as others after giving birth, and that this leaves them GABA-starved and vulnerable to postpartum depression or anxiety.
Brexanolone is a formulation of ALLO. The hypothesis is that if we give women ALLO postpartum to avoid the abrupt downward shift, this can prevent or treat postpartum depression. This is well worth studying, but it’s important to note that we don’t yet fully understand the role of ALLO in postpartum depression, or whether ALLO is a factor in a subset of women but not all women.Welcome to your blog post. Use this space to connect with your readers and potential customers in a way that’s current and interesting. Think of it as an ongoing conversation where you can share updates about business, trends, news, and more.
Developed by Women’s Mental Health
Office of Mental Health and Suicide Prevention (Veteran's Affairs)