FDA approves first postpartum depression drug

For the first time in history, the US Food and Drug Administration has approved a drug specifically indicated for the treatment of postpartum depression, which experts say offers new hope to women and physicians. The FDA announced the approval of an intravenous infusion of the drug brexanolone, which will be sold as Zulresso. It has been shown in clinical trials to work within hours to treat the symptoms of postpartum depression, a serious mental illness that impacts 1 in 9 new mothers after childbirth. CNN's Dr. Sanjay Gupta reports.

Posted: Mar 20, 2019 2:30 PM
Updated: Mar 20, 2019 2:30 PM

For the first time in history, the US Food and Drug Administration has approved a drug specifically indicated for the treatment of postpartum depression, which experts say offers new hope to women and physicians.

On Tuesday, the FDA announced the approval of an intravenous infusion of the drug brexanolone, which will be sold as Zulresso. It has been shown in clinical trials to work within hours to treat the symptoms of postpartum depression, a serious mental illness that impacts 1 in 9 new mothers after childbirth.

"Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said in a press announcement on Tuesday.

"Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient," she said.

The treatment is administered as a single 60-hour IV drip and was found to have mild side effects, such as headache, dizziness or excessive sleepiness, but also sudden loss of consciousness. Yet some women may face barriers accessing this type of treatment, as it requires 60 hours of time. The drug will likely be priced around $20,000 to $35,000 per treatment, Sage Therapeutics, the company that developed the drug, confirmed.

The initial list price for Zulresso in the United States will be $7,450 per vial, resulting in a projected average course of therapy cost of $34,000 per patient before discounts, according to the company. The actual number of vials used before discounts can vary from patient to patient.

The medication will be available in June, said Dr. Jeff Jonas, CEO of the Massachusetts-based biopharmaceutical company that developed the drug. The drug will be available only through a restricted program called the Zulresso Risk Evaluation and Mitigation Strategy (REMS) Program that requires the drug be administered by a health care provider in a certified health care facility, the FDA said in a news release announcing the approval.

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

Without any treatment, postpartum depression can last for months or even years, according to the National Institute of Mental Health. Studies showed the brexanolone was effective regardless of when postpartum depression symptoms began.

In the United States, it's estimated that every year, more than 400,000 infants are born to mothers who are depressed. Treatment options for postpartum depression have included counseling or therapy with a mental health professional and antidepressant medications, but no antidepressant medication has been specifically FDA-approved to treat postpartum depression. Also, antidepressant medications generally don't provide an immediate relief of symptoms and may take several weeks to help.

"Brexanolone in phase II and III trials demonstrated rapid antidepressant effects," said Deligiannidis, who is also an associate professor at the Feinstein Institute for Medical Research and member of the Anxiety and Depression Association of America.

Those effects are something that Stephanie Hathaway, a Connecticut-based mother of two, knows well.

A 'breakthrough' drug gets tested

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 troubling thoughts that she couldn't shake.

"The first two weeks I was crying excessively," Hathaway said. At first, her husband and she thought her tears were from "the baby blues," a feeling of sadness or emptiness after giving birth that goes away within a few days.

"But after that I had intrusive thoughts," she said. "Those were, 'Your daughter deserves a better mom,' and 'Your husband deserves a better wife.' "

Then Hathaway knew she needed help when one day she was holding her daughter and she feared what she might do to herself once she put her baby down.

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

A few years later, in 2017, Hathaway had a second child, and was prescribed the same antidepressants during that pregnancy -- but the medications were not helpful in relieving her symptoms.

A friend told Hathaway about clinical trials being conducted to evaluate the effectiveness of brexanolone in treating postpartum depression. Hathaway enrolled in a trial.

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

"Those intrusive thoughts that played on repeat in my head, those went away and didn't come back," she said, adding that as a side effect, "I just had one very small instance of standing up and feeling lightheaded."

In 2016, the FDA granted brexanolone a "breakthrough therapy designation" for the treatment of postpartum depression. Such a designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.

Results from two phase III trials of brexanolone, conducted across 30 clinical research centers and specialized psychiatric units in the United States, published in the journal The Lancet in August.

The trials, conducted in 2016 and 2017, involved more than 200 women who had symptoms of postpartum depression, which were assessed by standardized research scales. The women were followed up with over 30 days. Sage Therapeutics funded the research.

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

In the first study, by the end of 60 hours, the average reduction was 19.5 points in the brexanolone group that received smaller doses, and 17.7 points in the brexanolone group that received larger doses, compared with 14 points in the placebo group.

In the second study, which had only one brexanolone group, the average reduction in score was by 14.6 points in the brexanolone group compared with 12.1 points in the placebo group at 60 hours, the researchers found.

Overall, at 60 hours, about 75% of women who received brexanolone were at least 50% improved in their symptoms and about half of women who received brexanolone were no longer clinically depressed, Deligiannidis said.

Among the patients who had a response at 60 hours, 94% did not relapse at the 30-day followup.

The most common side effects included headache among 15.7% of patients; dizziness among 13.6%; and somnolence or excessive sleepiness among 10.7%, the researchers found.

The researchers wrote in the study that their findings "provide strong evidence for the efficacy and safety of brexanolone injection in women with moderate to severe post-partum depression."

Limitations of the studies include that the women were followed only for 30 days, so the duration of treatment effects beyond that were not included in the data.

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

Additionally in the trials, brexanolone had the most robust effects on women experiencing severe postpartum depression whereas results were more modest among others whose postpartum depression was less severe.

'It potentially sets a new standard for treatment'

"What has been consistent is that brexanolone had a very robust response -- and what's been most exciting to me, in terms of participating in this new drug development, was the rapid onset of response. The drug works quickly," said Dr. Samantha Meltzer-Brody, a professor of mood and anxiety disorders at the University of North Carolina School of Medicine in Chapel Hill, who was a researcher in those phase III trials for the drug.

"My greatest hope is that this increases awareness. What's heartbreaking is the number of women who suffer in silence and do not get the treatment that they need," she said. "People need to reach out and get screened and get treatment, regardless of if treatment is with brexanolone or not."

The clinical data supporting the effectiveness of brexanolone in helping women recover from postpartum depression sheds new light on the neurobiology of the illness, as well as depression during other life periods, said Catherine Monk, professor of medical psychology in obstetrics and gynecology and psychiatry at Columbia University Irving Medical Center and director of research in the women's program in psychiatry at NewYork-Presbyterian/Columbia University Irving Medical Center in New York. Monk was not involved in the drug trials.

Monk, who is also a research scientist at the New York State Psychiatric Institute, added that "because its effects are truly expedited, within days, it potentially sets a new standard for treatment for severe postpartum depression."

Minnesota Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 133802

Reported Deaths: 2402
CountyConfirmedDeaths
Hennepin34033991
Ramsey14073360
Dakota9823138
Anoka8661150
Washington593272
Stearns582543
Scott338234
Olmsted325230
St. Louis296569
Wright248314
Clay229743
Nobles226816
Blue Earth20437
Carver17897
Sherburne168522
Kandiyohi16705
Rice163310
Mower151717
Winona125019
Crow Wing101022
Chisago10022
Lyon9656
Benton9409
Waseca9289
Beltrami8917
Otter Tail8627
Todd8055
Steele7593
Nicollet73017
Itasca72717
Morrison7269
Douglas6963
Freeborn6694
Polk6434
Le Sueur6235
Martin61317
McLeod5974
Goodhue58511
Watonwan5784
Becker5614
Pine5430
Isanti5415
Chippewa4353
Carlton4341
Mille Lacs40615
Dodge3940
Hubbard3902
Wabasha3780
Cass3705
Pipestone35017
Rock3284
Meeker3263
Brown3213
Unassigned29053
Yellow Medicine2836
Cottonwood2800
Murray2783
Redwood27511
Roseau2640
Fillmore2600
Renville25211
Sibley2523
Faribault2310
Wadena2313
Jackson2101
Kanabec20910
Houston2041
Swift2011
Pennington1911
Lincoln1820
Stevens1821
Aitkin1792
Koochiching1694
Pope1560
Big Stone1380
Wilkin1344
Lac qui Parle1333
Marshall1211
Lake1190
Norman1150
Mahnomen1132
Clearwater1110
Grant984
Red Lake782
Traverse560
Lake of the Woods441
Kittson400
Cook160

Iowa Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 115574

Reported Deaths: 1621
CountyConfirmedDeaths
Polk18874288
Woodbury718394
Johnson584430
Black Hawk557498
Linn5513129
Dubuque518657
Scott454138
Story398918
Dallas344344
Pottawattamie323544
Sioux242516
Buena Vista225512
Marshall201436
Webster183015
Plymouth165727
Wapello152562
Clinton148326
Muscatine144258
Des Moines138610
Cerro Gordo136225
Crawford135514
Warren12477
Carroll114512
Jasper109634
Henry10545
Marion100710
Lee95410
Tama94437
Delaware77812
Dickinson7347
Wright7191
Boone7179
Mahaska68724
Bremer6719
Harrison65311
Washington65311
Jackson6283
Benton5812
Lyon5497
Clay5284
Louisa52115
Winnebago48719
Hardin4757
Winneshiek4749
Hamilton4684
Kossuth4660
Cedar4605
Poweshiek45611
Buchanan4514
Jones4444
Floyd43311
Emmet42917
Clayton4193
Iowa4059
Cherokee4022
Page3990
Mills3971
Sac3974
Guthrie39115
Cass3883
Franklin38018
Butler3782
Fayette3744
Shelby3721
Allamakee3638
Madison3603
Chickasaw3561
Clarke3493
Humboldt3233
Hancock3164
Palo Alto3102
Calhoun3074
Grundy3075
Osceola2791
Mitchell2750
Howard2699
Monroe25911
Monona2441
Jefferson2381
Taylor2362
Union2324
Appanoose2253
Pocahontas2232
Fremont2021
Lucas2016
Ida1922
Greene1860
Davis1764
Van Buren1742
Montgomery1737
Adair1611
Keokuk1601
Decatur1500
Worth1440
Audubon1421
Wayne1203
Ringgold882
Adams810
Unassigned260
Rochester
Clear
18° wxIcon
Hi: 32° Lo: 25°
Feels Like: 10°
Mason City
Clear
21° wxIcon
Hi: 33° Lo: 24°
Feels Like: 15°
Albert Lea
Clear
19° wxIcon
Hi: 32° Lo: 25°
Feels Like: 19°
Austin
Clear
21° wxIcon
Hi: 33° Lo: 25°
Feels Like: 21°
Charles City
Broken Clouds
19° wxIcon
Hi: 33° Lo: 24°
Feels Like: 13°
Temps gradually warming through the week!
KIMT Radar
KIMT Eye in the sky

Community Events