New mothers suffering from depression finally have a treatment that has been specifically approved for them. It's the second drug this month approved by the Food and Drug Administration to dramatically address depression. However, the treatment does not come without serious limitations in the application and will not necessarily be cheap. [FDA] approved Tuesday the Zulresso of Sage Therapeutics for the treatment of postpartum depression in adult women.
It is the first drug specifically developed for postpartum depression. It is estimated that 400,000 women in the US are affected each year. According to Samantha Meltzer-Brody, one of Zulrosso's senior investigators of clinical trials submitted to the FDA, this is a key need for this particular group.
"This drug is so important because the current treatment can take weeks to months. And postpartum depression can be so devastating to the mother, child, and family that it's imperative that treatments work quickly. Meltzer-Brody, clinical director of the Perinatal Psychiatry Program at the University of North Carolina's Chapel Hill, told Gizmodo. "This can treat women quickly and in a different way than we have been able to do so far."
The active substance in Zulresso is called Brexanolone, the synthetic version of a naturally-produced steroid called allopregnanolone. Allo, as it is known, interacts with a key receptor in the brain that controls the flow of the body's most important inhibitory neurotransmitter, GABA. Research has shown that women have high levels of Allo during pregnancy (along with another hormone, progesterone, that breaks down in Allo). But after delivery, allo levels decline in women, and it is this sudden drop, researchers speculate that GABA levels in the brain can be destabilized and lowered, which then contributes to postpartum depression and anxiety.
Allo has been associated with antidepressant effects for quite some time, but it has been a challenge to formulate and study possible treatments on this basis. Thanks to its chemical composition, it is not easily absorbed by the body when taken orally. To circumvent this limitation, Zulresso is an injectable version of the steroid.
In clinical trials reviewed by the FDA, it has been shown that the symptoms in patients with moderate to severe depression improve better on average than in those who received a placebo injection with standard antidepressants (due to their mode of action, the effect of these would have been Medication taken weeks). On Zulresso, more women reported a complete remission of their depression than the placebo group. These mood improvements were reported hours or days after initiation of treatment and lasted at least 30 days after treatment.
As with Spravato, the new ketamine-based nasal spray for depression, which was approved in early March, the FDA has put some severe 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 dizziness, dizziness, and most of all, fainting, women can only receive Zulresso in certified medical centers, including hospitals, where they need to be hospitalized throughout treatment.
The financial and personal costs of a two-day hospital stay can affect the availability of the medicine, as well as the direct cost of the medicine. Sage Therapeutics said the infusion costs about $ 34,000 per patient before discounts are granted. Although they assume that the insurance companies cover this, coverage and costs that remain will obviously vary from patient to patient.
According to Meltzer-Brody, Zulresso goes beyond the drug itself. Sage Therapeutics is developing another drug that affects GABA, similar to brexanolone, but can be taken orally – as well as 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 broader window of treatment for depression with new drugs and novel therapies. And I think that's a big step forward for the field, "she said.
Zulresso's experimental oral drug is in Phase 3 trials that have reported promising results so far, and Meltzer-Brody has been calling for ongoing long-term studies The drug is expected to be available to the public at the end of June, the company said in its announcement of FDA approval.