FDA approves drug to treat serious postpartum depression

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In the United States, the Food and Drug Administration (FDA) has approved the first drug specifically designed to treat severe depression after childbirth.

The drug, by the name of Zulresso, is expected to be available in the United States by the end of June. For the moment, the drug is to be given intravenously for two and a half days, but its manufacturer, Sage Therapeutics, is currently working on a pill.

The cost of the drug for treatment has been set at US $ 34,000. It is unclear at this time whether the drug company plans to apply for authorization to market the drug in Canada and elsewhere around the world.

Zulresso aims to restore to a normal level the amount of allopregnanolone, a derivative of progesterone, present in the blood of new mothers.

The level of progesterone, the female sex hormone, can drop, sometimes drastically after delivery. And several recent studies have shown that allopregnanolone, for its part, exerts an anxiolytic effect.

By mimicking allopregnanolone, the active ingredient in Zulresso, brexanolone, attempts to restore the hormonal balance in the patient who sees it administered.

The efficacy of Zulresso has been demonstrated in two Sage Therapeutics-funded clinical studies in new mothers with severe or moderate postpartum depression.

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According to the data collected, the depressive symptoms of these new mothers decreased at the end of treatment and the effects of the latter were still felt a month later.

Thus, after giving an intravenous infusion of Zulresso or a placebo for 60 hours to the participants, their depressive symptoms were evaluated on a scale of assessment of depression. They were then compared with the results obtained before administration of the drug.

Patients were reassessed one month after the end of treatment.

According to the FDA, “Zulresso demonstrated superiority over placebo in improving depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period.

The US agency notes, however, that some side effects were highlighted by the participants, the most common being drowsiness, dry mouth, unconsciousness and hot flashes.

Postpartum depression often ends on its own in a few weeks, but it can also last for months or even years. It can be treated by psychotherapy or antidepressants, which can take six to eight weeks to work, but are not always effective.

In severe cases, the mother may have suicidal tendencies, not wanting to breastfeed or want to attack her.

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Shakes Gilles

Editor of The Talking Democrat. He enjoys bike riding, kayaking and playing soccer. On a slow weekend, you'll find him with a book by the lake.