‘Brexanolone’ First FDA Approved Drug For Postpartum Depression

Brexanolone is the first FDA approved Postpartum Depression medicationPhoto By: Lars Plougmann/Flickr

Postpartum depression is frequently considered as a natural reaction of women’s body during or after pregnancy. However, this case is more severe than previously thought. The effects are destructing, not only to the lives of women but also to their families. In most cases, this increases marital stress which leads to divorce and reduces mother-infant bonding that may, later on, affect the social-development in a child’s life.

But things have changed, as the new treatment for the said illness paves the way to a wave of medications that can help women get through this situation.

The first-ever drug to help women suffering from postpartum depression has been approved by the Food and Drug Administration on Tuesday, a move that offers treatment to the painful condition that is the most common complication of childbirth.

The new drug called, Brexanolone, helps women cope with postpartum depression within 48 hours. The medication is a significant development over other anti-depressants that work but takes too much time (two weeks, to be precise) before the medicine to kick in. In some cases, it took even longer timeframe to a point where a specific dosage is administered to the patient.

Brexanolone, is a synthetic form of allopregnanolone, a hormone produced by progesterone in the brain that may help ease depression and anxiety by targeting neural activity, as per Dr. Samantha Meltzer-Brody, Director of the Perinatal Psychiatry program of the University of North Carolina at Chapel Hill, who was the chief investigator for the new drug.

Brexanolone, is a synthetic form of allopregnanolone
Brexanolone, is a synthetic form of allopregnanolone.

The approval marks the history in the medical field which is specially created to treat postpartum depression, providing another vital treatment option for women.

The drug which will be marketed under the brand name Zulresso, is administered by intravenous infusion over 60 hours during which the patient must remain in a certified medical center for observation in case she gets dizzy or faint similar to the after signs shown by some patients during clinical trials.

However, the infusion will be expensive. The new medication will cost patients between $20,000 and $35,000 plus the costs of staying in a medical center for two and a half days. Officials say that the price will be minimized as long as insurers will cover the treatment. Insurance and health benefits companies said that they are going to evaluate the drug later this week.

Brexanolone is also the first-ever drug developed and approved by Sage Therapeutics.

However, a pill version that is much more accessible and easier for patients is showing development in its clinical trials. According to the manufacturer, Sage Therapeutics, the pill will be submitted for approval in a couple of years if the results of the test show a promising record.

Before the approval of Brexanolone, anti-depressant medications and a wide range of therapies including interpersonal, behavioral, and cognitive have been the alternatives offer to treat postpartum depression. Other treatments may provide relief such as psychodynamic therapy, light therapy, exercise, and yoga, but provide strenuous activities to the patients.

A study conducted by the Anxiety and Depression Association of America, the class of medications prescribed for postpartum depression is fluoxetine and sertraline, but may showcase risk to infants through breastfeeding.

Today the infusion of Brexanolone may be delivered just once, and patients are also advised to rake standard anti-depressants. With the intake of the new drug, clinical trials, all subsidized by Sage, found that it produced a sudden decrease in symptoms among women with severe and moderate postpartum depression than a similar palliative infusion. It is believed that the relief from depression continued for within a month after the treatment.

While some anecdotal reports showed that relief might be extended beyond that period for some women, there is still no systematic research on long-term results. However, Dr. Margaret Spinelli, a clinical professor of psychiatry at Columbia University, who specializes in treating postpartum depression, said that the significant point is the rapid effect of the drug and that alone is enough to design other medications for postpartum depression in a more accessible way.

The treatment is a breakthrough in the clinical field and may be helpful to the 30 percent of women who experiences postpartum depression. According to the Centers for Disease Control and Prevention, approximately 400,000 women experience postpartum depression each year in the US. The number continues to increase annually, but only about half of women are diagnosed and treated.

With the new drug, candidates for treatment would be those who experience severe symptoms or patients who failed to improve on standard antidepressants.

Dizziness and sleepiness were the most common side effects in the trials, but the most troublesome consequences will be fainting or loss of consciousness. And, another concern is the expense of the treatment and the need for patients to be admitted to medical centers. These may be worth it primarily for the patients who don’t have the patience to wait for four weeks for an anti-depressant to kick in or those whose families are being compromised because of the illness.

The research presented to the FDA has three clinical trials that were funded by Sage Therapeutics which also involved in the study design, data analysis, and interpretation of the reports. The women in the experiment are all mothers who had just gave birth and experienced depression within four weeks after childbirth.

Postpartum depression is a severe condition which can be life-threatening, and in most cases, may result in marital separation. This game-changing development is rare and different from other clinical drugs out there.

Today, experts say that the new treatment will provide immediate relief for mothers who often go untreated and may offer hope, changing the way they view about life for the first time.

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