How the First Drug Approved to Treat Postpartum Depression Was Approved

Postpartum depression is one of the most common medical complications during and after pregnancy. It is thought to affect about one in eight women who give birth.

The disorder, which can start during pregnancy and persist for several months after delivery, is usually treated with talk therapy and medication, mainly antidepressants.

However, existing antidepressants, mainly so-called selective serotonin reuptake inhibitors (SSRIs), can take weeks or even months to take effect in patients.

So far, the only specific treatment for postpartum depression is intravenous.

But now the first specific oral drug for the disease, called zuranolone, has just been approved.

Clinical trials have shown that the drug can help significantly reduce disease symptoms within days.

The U.S. Food and Drug Administration (FDA) said zuranolone is approved as a drug to be taken once daily for two weeks and then discontinued.

The drug is expected to be available later this year, although its price is unknown, as announced by its makers, Sage Therapeutics and Biogen.

grief and loss of energy

Like other forms of depression, symptoms of postpartum depression include sadness, loss of energy, thoughts of suicide, decreased ability to feel happy, or cognitive decline.

“Postpartum depression is a serious and life-threatening disorder in which women experience feelings of sadness, guilt, worthlessness and, in severe cases, thoughts of harming themselves or their children,” said Tiffany Farchione, director of psychiatry in the FDA’s Center for Drug Evaluation. ” and research.

“As postpartum depression can disrupt the mother-infant relationship, it can also have an impact on the child’s physical and emotional development.”

She added that access to oral medications is beneficial for many women “coping with extreme and sometimes life-threatening feelings.”

Clinical trials of the drug showed that the pill helped significantly reduce symptoms of depression within three days, the FDA said.

And the effect was maintained up to four weeks after the last dose.

Zuranolone belongs to a class of drugs that act on the brain called neuroactive steroids.

Unlike most antidepressants on the market today that work by increasing the activity of neurotransmitters that affect mood and mood, zuranolone acts on the receptor in the brain, GABA-A, which is believed to play a role in depression play a role in.

side effect

The most common side effects of zuranolone may include drowsiness, dizziness, diarrhea, fatigue, common cold and urinary tract infections, the FDA noted.

The drug’s label will carry a warning that it may affect a person’s ability to drive and perform other potentially dangerous activities, the agency said.

And advise patients not to drive or operate heavy machinery for at least 12 hours after taking it.

Sage Therapeutics and Biogen are also seeking approval for zuranolone to treat major depressive disorder (clinical depression).

However, the FDA said the drug provided no substantial evidence of effectiveness and said one or more additional studies were needed.

Still, as a treatment for postpartum depression, zulanorolone joins a crowded market of antidepressants.

Although they will face a lot of competition, their makers believe the drug will be an attractive option primarily for patients who do not respond to current treatments.

According to experts, about one-third of people who try antidepressant treatment do not experience improvement in their symptoms.

“The sooner we can intervene and help patients achieve remission and remission, the better the long-term outcomes for patients,” said Chris Bennechi, business director for Sage Therapeutics.

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BBC-NEWS-SRC:, import date: 2023-08-07 12:40:11

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