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FDA approves first postpartum depression drug



For the first time in history, the US Food and Drug Administration (FDA) has approved a drug specifically for the treatment of postpartum depression that, according to experts, offers women and doctors new hope.

On Tuesday, the FDA announced approval for approval of an intravenous infusion of the drug Brexanolone, which is sold as Zulresso. Clinical studies have shown that the symptoms of postpartum depression are treated within hours, a serious mental illness affecting 1 in 9 new mothers after birth.

Treatment is the only 60-hour IV drip to treat mild side effects such as headache, dizziness, or excessive drowsiness. However, for some women, there may be barriers to accessing this type of treatment as it takes 60 hours. The drug is expected to cost between $ 20,000 and $ 35,000 per treatment, confirms Sage Therapeutics, the company that developed the drug.

The initial list price for Zulresso in the United States will be $ 7,450 per vial, resulting in an expected average course of treatment. Therapy costs were $ 34,000 per patient before deductions, according to the company. The actual number of vials used before discounts may vary from patient to patient.

The drugs will be available in June. Jeff Jonas, CEO of the Massachusetts-based biopharmaceutical company that developed the drug. The drug will only be available through a limited program called the Dementia Risk Assessment and Mitigation Strategy (REMS), which prescribes the administration of the drug by a healthcare provider in a certified healthcare facility a press release announced the approval.

"There are no FDA-approved antidepressants for postpartum depression, and approval of the first drug of its kind is a breakthrough for patients," said Dr. Kristina Deligiannidis, director of Women's Behavioral Health at Northwell Health's Sugar Hillside Hospital in New York, was involved in two clinical trials of the drug as a researcher.

Postpartum depression may last for months or even years without treatment, according to the National Institute of Mental Health. Studies showed that brexanolone was effective regardless of the time of onset of postpartum depression.

In the United States, it is estimated that every year more than 400,000 infants are born from depressed mothers. Treatment options for postpartum depression include counseling or therapy with a psychiatrist and antidepressants, but no antidepressant has been specifically approved by the FDA for treatment of postpartum depression. Antidepressants are generally not an immediate symptom relief and can take several weeks to help.

"Brexanolone has demonstrated rapid antidepressant effects in Phase II and III studies," said Deligiannidis, who is also a professor at the Institute's Feinstein Institute for Medical Research and a member of the Anxiety and Depression Association of America.

Stephanie Hathaway, mother of two children in Connecticut, is well aware of these effects.

A Breakthrough Drug Is Tested [1
9659012] When Hathaway brought her first baby home from the hospital, she was just as excited and nervous as most new moms – but she also experienced crying spells and restless thoughts that she could not shake ,

"The first two weeks I was crying overly," Hathaway said. At first, her husband and she believed that their tears came from "the baby blues," a sense of sadness or emptiness after birth that disappeared within a few days.

"But after that, I had intrusive thoughts," she said. "These were:" your daughter deserves a better mother "and" your husband has earned a better wife.

Then Hathaway knew that she needed help when she kept her daughter one day and feared she might harm herself as soon as she laid her baby down.

This year, Hathaway was diagnosed with postpartum depression in 2014 and treated with traditional antidepressant medications, which she said helped "over time."

Several years later, in 2017, Hathaway had a second child and was prescribed the same antidepressants during that pregnancy – the medications were however, not helpful in relieving the symptoms.

A friend told Hathaway about clinical trials investigating the efficacy of brexanolone in the treatment of postpartum depression, and Hathaway participated in a study

"It was one 60-hour infusion, and in the first 12 to 18 hours, I felt the biggest difference, "said Hathaway.

" This intrusive G editors that repeat themselves in my head, these went away and did not come back, "she said, adding, as a side effect, I added," I had only a very small instance of getting up and drowsiness. "

In 2016, the FDA granted Brexanolone a" Breakthrough Therapy Mark "for the treatment of postnatal depression. Such a name is intended to accelerate the development and testing of medicines for serious or life-threatening illnesses.

Results from two phase III studies with brexanolone, which were conducted at 30 clinical research centers and specialized psychiatric units in the United States, published in The Lancet magazine in August.

The studies conducted in 2016 and 2017 involved more than 200 women with symptoms of postpartum depression assessed using standardized research scales. The women were observed with over 30 days. Sage Therapeutics funded the research.

In these studies, some women received 60-hour IV infusions with smaller or larger doses of brexanolone, while others received placebo. The researchers found that the women who received the brexanolone infusions had "significant and clinically meaningful" reductions in their depression scores.

In the first study, the mean reduction at 60 hours in the obtained brexanolone group was 19.5 points lower doses and 17.7 points in the brexanolone group, which received larger doses compared to 14 points in the placebo. Group.

In the second study, which had only one Brexanolone group, the average decrease in group score was 14.6 points. The Brexanolone group compared with 12.1 points in the placebo group after 60 hours, the researchers found researchers.

In total, about 75% of women who received Brexanolone had at least 50% improvement in their symptoms and about half of women after 60 hours. Patients receiving Brexanolone were no longer clinically depressed

. Among the patients who responded after 60 hours, 94% did not appear at the 30-day follow-up.

Mon side effects included headache in 15.7% of patients; Dizziness at 13.6%; and somnolence or excessive drowsiness at 10.7%, the researchers found.

Researchers wrote in the study that their findings "provided strong evidence for the efficacy and safety of the Brexanolone injection in women with moderate to severe postpartum depression." [19659002] Among the limitations of the studies is that women were only observed for 30 days, so the duration of the treatment effects was not included in the data.

The treatment also requires an IV of 60 hours – which is for women without support to live at home or in poverty, could be difficult. Low-income mothers are at high risk for postpartum depression. The treatment could also interrupt breastfeeding and patients are encouraged to discuss the risks and benefits of breastfeeding with their doctor.

In the studies, Brexanolone also had the most robust effects on women suffering from severe postpartum depression, while the results were more modest among others, whose postpartum depression was less pronounced.

"It may set a new standard for treatment"

"The consequence is that Brexanolone had a very robust response – and what's most exciting about me in terms of participation. This new drug development was the rapid onset of the response The drug works fast, "said Dr. Samantha Meltzer-Brody, Professor of Mood and Anxiety Disorders at the Medical Faculty of the University of North Carolina at Chapel Hill, who researched the drug in these Phase III trials.

"My greatest hope is that it increases consciousness. Heartbreaking is the number of women who suffer in silence and do not receive the treatment they need, "she said. "People need to get in touch, undergo examination and treatment, regardless of whether or not they are taking Brexanolone."

The clinical data supporting the efficacy of Brexanolone in women's recovery from postpartum depression shed new light on the neurobiology of the disease and depression during other periods of life, said Catherine Monk, a professor of medical psychology in obstetrics and obstetrics Gynecology and Psychiatry at the Columbia University Irving Medical Center and Research Director of the Women's Program in Psychiatry at the New York-Presbyterian / Columbia University Irving Medical Center in New York. Monk was not involved in the drug trials.

Monk, who is also a scientist at the New York State Psychiatric Institute, added, "Since its effects are really accelerating, within a few days this may set a new standard for treatment of major postpartum depression. "


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