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April 4, 2019
by Elizabeth Pratt

FDA Approves First Drug For Postpartum Depression

April 4, 2019 08:00 by Elizabeth Pratt  [About the Author]

The US Food and Drug Administration has approved the first drug designed specifically for the treatment of postpartum depression (PPD). 

The new drug, brexanolone, is an intravenous medication designed to help relieve symptoms as quickly as in two and a half days. It is the first of its kind to specifically target postpartum depression.

“This is very significant… this is a drug developed for a female only disease, and not only a medical disease a mental health disease” Dr. Catherine Birndorf, a reproductive psychologist and spokesperson for Postpartum Support International told Theravive.

“I’m thrilled that we might have a new tool in our toolbox… that we may have a new drug that particularly treats acute women, women who are suicidal and profoundly depressed and incapacitated. We don’t have something right now that pulls somebody out of that deep dark hole, that could save a life in that sort of immediate way,” she said.

Postpartum depression is a depressive period that can appear following the delivery of a baby. Unlike the baby blues, (feelings of stress, sadness or anxiousness following birth that are normal and go away on their own), postpartum depression will not resolve unassisted and can continue for weeks or months without treatment.

Women experiencing postpartum depression may find it hard to get through the day, care for themselves or care for their baby.

Reported rates of clinical postpartum depression in new mothers is between 10 to 20 per cent. Some studies estimate one in seven women experience PPD in the year following birth. This is the equivalent of about 600 000 diagnoses of postpartum depression every year in the United States.

Birndorf says the new drug is indicative of changing attitudes towards a disease that has long been misunderstood.

“Normally you have a disease and you develop drugs for it, but this disease has been around a long time. Understanding women, researching women… has not been a priority,” she said.

“It legitimises the illness having big pharma making a drug for it.”

Although a step in the right direction, experts have raised concerns as to the practicalities of everyday women being able to access the drug.

Brexanolone will only be available to patients through a restricted program. The drug can only be administered by a health care provider in a health care facility that is certified. The drug is administered intravenously over a period of two and a half days, requiring patients to stay overnight. Patients must be monitored for excessive sedation due to the risk of harm from a sudden loss of consciousness. Oxygen levels in the blood must be constantly monitored during the infusion and patients must be accompanied by another person when interacting with their children during the administration of the drug.

Sage Therapeutics, the drug’s developer have listed the cost of the drug as between 20 thousand and 35 thousand dollars for each course of treatment.

Birndorf, who is also author of the book What No One Tells You: A Guide To Your Emotions From Pregnancy To Motherhood, says the price, as well as the restrictions surrounding administering of the drug could make it difficult for the average woman to benefit.

“There are a lot of obstacles for it to be mainstream and available to all. It’s incredibly expensive, it’s difficult to administer, it requires an overnight stay and it’s only been tested up to 30 days out. So does it last? We have no idea,” she said.

Although brexanolone is the first drug specifically targeting postpartum depression, other treatment options are available. Treatment options may include psychotherapy, also referred to as talk therapy, where patients talk through issues with a psychologist, psychiatrist or other registered mental health professional. Medications like antidepressants can also be used to treat the symptoms of postpartum depression.

“We already can treat this, the problem isn’t treatment. It’s just we don’t talk about it,” Birndorf said.

“With help, with treatment, you can get better, you can feel better, you will recover. The message is one of hope. Everyone should speak up as best they can, if you know you’re off, if you know something’s not right, you have to tell someone, find someone you trust, don’t take no for an answer. Don’t be deterred, persist even though it’s so hard, there is treatment and with help you can get better,” she said.

Although there are still many obstacles facing women seeking treatment with brexanolone, Birndorf says it is a step in the right direction. She say the potential speed of treatment in only a few days is promising, but more importantly the FDA’s approval of the drug legitimises a condition that has caused many women to feel shame.  

“It’s progress, it’s movement forward and it’s recognition of a long under recognised, under diagnosed under treated and under talked about, real illness,” she said.

 

About the Author

Elizabeth Pratt

Elizabeth Pratt is a medical journalist and producer. Her work has appeared on Healthline, The Huffington Post, Fox News, The Australian Broadcasting Corporation, The Sydney Morning Herald, News.com.au, Escape, The Cusp and Skyscanner. You can read more of her articles here. Or learn more about Elizabeth and contact her via her LinkedIn and Twitter profiles.


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