The FDA is expected to approve a postpartum depression drug for the first time – it could help hundreds of thousands of new mothers


This update corrects the spelling of the Marie McCausland surname.


Marie McCausland gave birth to a boy, Jeffrey, in the Mother's Day of 2017.

The happy occasion was quickly spoiled by a serious medical emergency. Four days later, McCausland was hospitalized for postpartum preeclampsia, a rare but serious condition that can lead to convulsions, strokes and other life-threatening complications.

McCausland, who is 28 and lives in Cleveland with her husband and son, returned to her work as a researcher on HIV 10 weeks after her ordeal. But something was wrong. He had just had a beautiful baby who had his blue eyes, but he didn't feel well.

She felt exhausted and sad. He felt guilty all the time. He started having panic attacks.

"I think you have a postpartum depression," her husband told her.

Postpartum depression affects one in nine women in the United States, according to the Centers for Disease Control and Prevention. Symptoms include feeling sad or in tears, suicidal thoughts, inability to take pleasure in things that were once pleasant, inability to concentrate and a change in sleep patterns. It is associated with worse nutrition and health in the newborn and can interfere with breastfeeding and the mother-infant bond. It can happen during or after a pregnancy.

McCausland didn't think he had a postpartum depression. He did not feel detached from his son; she loved it to pieces. She was just tired of the pre-eclampsia episode and worked, she insisted with her husband.

But his mood plummeted down over the next few months and, after an accident in which he imagined himself dead in his closet, he decided it was time to get help. It was not easy – although he was able to see a psychiatrist quickly enough, it took more than a month to get an appointment with a therapist.

A new treatment for postpartum depression, called brexanolone, should be approved by the Food and Drug Administration this month. Developed by Sage Therapeutics Inc.

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which plans to market the drug under the name of Zulresso, would be the first drug therapy approved to specifically treat postpartum depression.

Postpartum depression is usually managed through psychotherapy and antidepressant drugs, which is what McCausland's psychiatrist recommended. But those treatments can take weeks to take effect. In the case of McCausland, it took a couple of months, he said.

Brexanolone, which is given as an intravenous infusion over 60 hours, should start working within a few days.

The main component of the injection of brexanolone is allopregnanolone, a metabolite of progesterone that binds to receptors of the gamma-aminobutyric acid in the brain that play a role in regulating the mood. The amount of allopregnanolone in the body increases during pregnancy and falls rapidly after delivery.

The results of two randomized phase 3 brexanolone studies published in The Lancet in September showed that the drug could significantly improve the symptoms of postpartum depression within a few days. The researchers examined the effect of brexanolone on 246 women with moderate to severe postpartum depression. They used a survey called the Hamilton Rating Scale for Depression (HAM-D) to assess the severity – the higher the score, the more severe the depression.

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After 60 hours, HAM-D scores decreased more in brexanolone groups than in placebo groups. The effects were lasting; 30 days later, depression scores in the treatment groups did not return to baseline and remained lower than those in the placebo groups.

"This is unlike anything we currently have at our disposal," said Samantha Meltzer-Brody, lead author of the study and director of the program for perinatal psychiatry at the University of North Carolina at Chapel Hill . "Now we have the opportunity to treat women quickly, in a few days."

The main side effects of the drug were headache, dizziness and drowsiness. One patient lost consciousness during the infusion, but regained it when the infusion was reduced.

The drug will probably be priced at $ 20,000 to $ 35,000 per treatment, according to Michael Cloonan, Sage's Chief Business Officer. The company is currently working with payers to iron out the coverage specifications and is looking at a launch date in June, he said.

Brexanolone may not be suitable for everyone. The 60-hour infusion is likely to be of more interest to women with severe symptoms who need rapid relief, said Ruta Nonacs, a psychiatrist at the Ammon-Pinizzotto Center for Women's Mental Health at Massachusetts General Hospital who does was involved in the trials. Some mothers may also have difficulty leaving their families for the time needed for treatment.

"This is a break big enough to be hospitalized for two or three days," he said.

However, brexanolone could be a "godsend" for mothers suffering from severe depression or mothers who have not responded to other treatments, said Dr. Nonacs. "There is still an urgent need for drugs to resolve depressive symptoms more quickly than is currently available," he said.

To read: FDA approves Johnson & Johnson's ketamine-like drug for the treatment of severe depression

The researchers are working on it. At the beginning of this month, the FDA approved Johnson & Johnson & # 39; s

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Rapid-acting nasal spray for severe depression called esketamina, a close chemical relationship with ketamine. Sage is developing an oral drug with an action mechanism similar to that of brexanolone for the treatment of postpartum depression and major depressive disorder.

"We think this is a new mechanism that has not been explored before," said Sage CEO Jeff Jonas.

"Zulresso is, in many respects, only the tip of the spear," he said.



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