New mothers suffering from postpartum depression finally have a treatment approved specifically for them. It’s the second drug this month approved by the Food and Drug Administration to address depression in a dramatically different way. But the treatment won’t come without serious restrictions on its use, nor will it necessarily be cheap.
On Tuesday, the FDA approved Sage Therapeutics’ Zulresso for the treatment of postpartum depression in adult women. It’s the first drug tailored specifically for postpartum depression, which is estimated to affect 400,000 women annually in the U.S. And according to Samantha Meltzer-Brody, one of the lead investigators of the clinical trials for Zulresso submitted to the FDA, it’s an essential need for that particular group.
“This drug is so important because current treatments can take weeks to months to work. And postpartum depression can be such a devastating disorder for the mother, her baby, and family, that there’s been a great need for treatments that work quickly,” Meltzer-Brody, a clinical director of the Perinatal Psychiatry Program at the University of North Carolina Chapel Hill, told Gizmodo. “This can treat women quickly and unlike any other way we’ve been able to do before.”
The active ingredient in Zulresso is called brexanolone, the synthetic version of a naturally produced steroid called allopregnanolone. Allo, as it’s also known, interacts with a key receptor in the brain that helps control the flow of the body’s major inhibitory neurotransmitter, GABA. Research has shown that women have high levels of allo during their pregnancy (along with another hormone, progesterone, that breaks down into allo). But following delivery, levels of allo fall in women, and it’s this sudden drop-off, researchers have speculated, that can destabilize and decrease levels of GABA in the brain, which then contributes to postpartum depression and anxiety.
Allo has been linked to antidepressive effects for some time now, but it’s been a challenge to formulate and study potential treatments based on it. Thanks to its chemical makeup, it isn’t 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 was shown to improve symptoms on average better in patients with moderate-to-severe depression than in those given a placebo injection along with standard antidepressants (due to how they work, the effects of these drugs would have taken weeks to kick in). More women on Zulresso also reported a full remission of their depression than did the placebo group. These improvements in mood were reported hours or days after treatment began and lasted at least 30 days following the treatment.
As with Spravato, the new ketamine-based nasal spray for depression approved earlier this March, the FDA has placed 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 most dangerously, fainting, women can only get Zulresso at certified medical centers, including hospitals, where they’ll have to be monitored as an in-patient for the entire treatment.
The financial and personal costs of a two-day-long hospital stay may hamper the drug’s availability, though, as might the drug’s direct costs. Sage Therapeutics has said the infusion will cost around $34,000 per patient, before discounts are applied. And though they expect insurance companies to cover it, the level of coverage and out-of-pocket costs left behind will obviously differ from patient to patient.
According to Meltzer-Brody, Zulresso’s importance extends beyond the drug itself. Sage Therapeutics is developing another drug that affects GABA, similar to brexanolone, but which can be taken orally—as are other drug companies. These GABA-based drugs may not only work for women with postpartum depression, but other populations too, including people with chronic depression that hasn’t responded to conventional treatment.
“Postpartum depression may be the window into treating depression more broadly, with new drugs and novel therapies. And I think that’s a great step forward for the field,” she said.
Zulresso’s experimental oral drug is undergoing Phase 3 trials, which have reported promising results so far. Meltzer-Brody also called for ongoing long-term studies of Zulresso, including measuring how long its effects can last past 30 days. The drug is expected to be available to the public by late June, the company said in its announcement of the FDA approval.