One of every seven novice mothers is deeply troubled by postpartum depression. Has their gospel come? About 15% of new mothers worldwide suffer from postpartum depression. This is a huge group of patients with special depression, but they are often labeled as “hypocritical” and “fragile”, and their condition is ignored by their families until tragedy occurs.
According to the research in endocrinology and other fields, after the child is born, some hormones in the maternal body will fall precipitously, which is powerful enough to destroy a strong willed man. However, for a long time, the effective rate of drugs for the treatment of postpartum depression is not high and the cycle is long. If pregnant again, there is still a recurrence rate of 20% ~ 30%.
Recently, this field has finally ushered in a breakthrough. The U.S. Food and Drug Administration (FDA) approved a drug specifically for the treatment of postpartum depression on March 19, 2019, claiming that it can take effect within 48 hours. However, this new gospel is also accompanied by a high price: according to sage’s official website, the drug, zulresso (commonly known as brexanolone), retails for $7450, equivalent to $34000 per course of treatment.
After having a baby, Stephanie Hathaway’s life changed. The first time she held the child in her arms, she was very happy and nervous. But for the next two weeks, she spent it crying. Many bad feelings overwhelmed her, “my daughter should have a better mother, and my husband should have a better wife. And my future is hopeless. ”
These thoughts repeat themselves every day. She had no mind to cook, cut off society and lost all the fun of life. In 2014, the mother from Connecticut was diagnosed with postpartum depression (hereinafter referred to as PPD). In the years after delivery, she has been living in anxiety and despair, accompanied by strong sadness.
Hathaway is one of 15% of PPD patients in the world. According to this ratio, one in seven pregnant women suffers from this hidden mental disease, and 20% of postpartum deaths are suicide due to depression. These data come from a large-scale survey conducted by Northwestern University in 2013. Moreover, it is only the conservative data in many surveys.
The etiology of postpartum depression is complex, including social, genetic and psychological factors. From a biological point of view, it is related to the drastic changes in the level of estrogen and progesterone: after delivery, some hormones in pregnant women are reduced ten times, showing a cliff decline, which seriously affects their neuroendocrine, neurotransmitters and changes in biological rhythm. But for a long time, PPD has taken the same treatment scheme as ordinary depression, which takes four or five weeks to take effect, sometimes longer. And for another 30% – 50% of patients, these drugs don’t work at all.
Previously, Hathaway had been struggling with the antidepressant Zoloft. Depression returned after the second child was born in 2017. Everything goes back to the origin. If she couldn’t hold her child in her arms, she would hurt herself, which made her think of suicide many times. Desperate, Hathaway signed up as a mouse and became the experimental object of psychiatrist Samantha Meltzer Brody to try a new drug.
Samantha is from the Department of psychiatry at the University of North Carolina and serves as the director of the perinatal psychiatry program of the UNC Center for women’s mood disorders. Engaged in PPD treatment for 25 years, she has witnessed countless PPD patients with different grief, anxiety, irritability, self closure, self mutilation and suicide. In her opinion, for these women and their families, rapid treatment of PPD is the real gospel.
After years of research, Samantha’s team decided to focus on γ- Aminobutyric acid type A (GABAA) receptor. GABAA is the “messenger” of the central nervous system. It is responsible for connecting the signal to the correct receiver. If it is not connected, there will be emotional problems. Therefore, GABAA can be regarded as a key and the receiver is a keyhole. Changing the size of the keyhole can regulate the activity of the receptor and control the transmission of cellular signals, so as to achieve the therapeutic effect. In this way, the treatment time can be greatly reduced.
Their research result is an injection called brexanolone. In 2017, five months after the second child was born, Hathaway injected brexanolone. 12 hours later, the thoughts hovering in her mind disappeared. Walking out of the hospital, she said, “I feel like I’ve found myself again.”
Expensive gospel, promising future
On August 31, 2018, the Lancet published the research results. According to the clinical data disclosed in the article, the research team collected 247 patients for three-phase experiment. In the first phase of the experiment, the patients were divided into injection group and placebo group. Before administration, the total HAM-D score (a common index to measure the severity of depression) of the two groups were 25.5 and 25.7 respectively. 60 hours after administration, the injection group improved significantly, and the score decreased by 17.0 points, while the placebo group decreased by 12.8 points.
Overall, 75% of the patients who received the injection improved significantly, and nearly half of the patients had no symptoms of depression. During the 30 day follow-up, 94% did not relapse. In terms of adverse reactions, 10% of patients had headache, dizziness and drowsiness, and 13.6% had dizziness.
The study was funded by SAGE therapeutics. In August 2018, driven by sage, brexanolone was submitted to the U.S. Food and Drug Administration (FDA) and the European Drug Administration (EMA) for listing approval, so as to enter the market.
On March 19, 2019 local time, FDA issued a notice officially announcing that brexanolone was approved for listing. Unlike conventional oral drugs, patients must be injected in a certified hospital for more than 60 hours. Because of the risk of dizziness and even syncope, they must be hospitalized and supervised.
Compared with other drugs, brexanolone is also an expensive gospel. Each course of treatment costs about $34000, not including hospitalization. Fortunately, in recent years, there have been more and more breakthroughs in medical technology for depression and postpartum depression. For example, in early March 2019, FDA approved the listing request of a new antidepressant drug, Spravato, which is a nasal spray with ketamine as its main ingredient. It is also the first 4-hour effective new drug for patients with refractory depression in 35 years.
Brexanolone is the first antidepressant specifically for postpartum pregnant women. Clinical studies also show that brexanolone is effective no matter when the symptoms of postpartum depression begin“ These data and research have taken an exciting step and led us into the treatment of special groups whose mental disorders have been ignored for too long. ” Said Steve Kanes, sage’s chief medical officer.