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New mothers with postpartum depression finally have a treatment approved specifically for them. This is the second drug approved this month by the Food and Drug Administration to treat depression in a radically different way. But the treatment will not be without serious restrictions on its use, and will not necessarily be cheap.
On Tuesday, the FDA approved Zulresso of Sage Therapeutics for the treatment of postpartum depression in adult women. It is the first drug specifically designed for postpartum depression, affecting 400,000 women a year in the United States. According to Samantha Meltzer-Brody, one of the leading investigators of clinical trials on Zulresso submitted to the FDA, this is a critical need for this particular group.
"This drug is so important because current treatments can take weeks or even months. And postpartum depression can be such a devastating disaster for the mother, her baby and her family, that there is an urgent need for prompt treatment, "said Meltzer-Brody, clinical director of the Perinatal Psychiatry Program. University of North Carolina. Chapel Hill, told Gizmodo. "It can treat women quickly and unlike any other means we have been able to before."
The active ingredient of Zulresso is called brexanolone, the synthetic version of a steroid naturally called allopregnanolone. Allo, as we know, interacts with a key brain receptor that helps control the flow of the body's main inhibitory neurotransmitter, GABA. Research has shown that women have high allo rates during their pregnancy (with another hormone, progesterone, which breaks down into allo). But after delivery, women's fall rates dropped, and the researchers speculated that this sudden drop could destabilize and reduce levels of GABA in the brain, which then contributes to depression and depression. postpartum anxiety.
Allo has been associated with antidepressant effects for some time, but it has been difficult to formulate and study potential treatments based on these effects. Due to its chemical composition, it is not easily absorbed by the body when taken orally. To get around this limitation, Zulresso is an injectable version of the steroid.
In clinical trials reviewed by the FDA, it has been shown that symptoms generally decrease better in patients with moderate to severe depression than in those receiving a placebo injection with standard antidepressants (due to their their effects would be more effective, took weeks to come into play). More women under Zulresso also reported complete remission of their depression compared to the placebo group. These mood enhancements were reported a few hours or days after the start of treatment and lasted at least 30 days after treatment.
As with Spravato, the new nasal spray against ketamine-based depression approved earlier in March, the FDA has imposed some serious conditions on the use of Zulresso. The treatment requires a single infusion over a period of 60 hours, or two and a half days. And because of side effects such as drowsiness, dizziness and, dangerously, fainting, women can only get Zulresso in approved medical centers, including hospitals, where they will have to be followed throughout the treatment.
The financial and personal costs of a two-day hospital stay can affect the availability of the drug, as well as its direct costs. Sage Therapeutics said the infusion would cost about $ 34,000 per patient before the discounts are applied. And although they expect insurance companies to cover it, the level of coverage and the costs that remain to be paid will obviously be different from one patient to the next. " other.
According to Meltzer-Brody, the importance of Zulresso is not limited to the drug itself. Sage Therapeutics is developing another drug that affects GABA, similar to brexanolone, but that can be taken orally, just like other pharmaceutical companies. These GABA-based drugs may not only work for women with postpartum depression, but also for other populations, including people with chronic depression who have not responded to conventional treatment.
"Postpartum depression can be a window into the more general treatment of depression, with new drugs and new therapies. And I think it's a big step forward for the field, "she said.
Zulresso's experimental oral drug is currently undergoing Phase 3 trials, which have yielded promising results so far. Meltzer-Brody also called for continued long-term studies on Zulresso, including the measure of how long its effects can last for 30 days. The drug is expected to be available to the public by the end of June, the company said in its announcement of FDA approval.
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