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 8:37 AM


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.

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. 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."

Terre Haute
Partly Cloudy
22° wxIcon
Hi: 37° Lo: 21°
Feels Like: 14°
Robinson
Partly Cloudy
17° wxIcon
Hi: 38° Lo: 20°
Feels Like: 17°
Indianapolis/Eagle Creek
Partly Cloudy
22° wxIcon
Hi: 31° Lo: 22°
Feels Like: 13°
Paris
Partly Cloudy
19° wxIcon
Hi: 34° Lo: 20°
Feels Like: 19°
Mattoon/Charleston
Partly Cloudy
18° wxIcon
Hi: 38° Lo: 19°
Feels Like: 18°
Terre Haute
Partly Cloudy
22° wxIcon
Hi: 35° Lo: 20°
Feels Like: 14°
Terre Haute
Partly Cloudy
22° wxIcon
Hi: 37° Lo: 21°
Feels Like: 14°
Cloudy, Breezy & Cold
WTHI Planner
WTHI Temps
WTHI Radar

Latest Video

Image

Wednesday: Becoming sunny. Breezy. High: 38°

Image

THN Shakamak

Image

West Vigo Bloomfield

Image

Loogootee Evan Memorial

Image

North Daviess Dugger Union

Image

Vincennes Rivet Evan Central

Image

Vin Lincoln Evan Mater Dei

Image

TH North Nothview

Image

Caitlyn Newton

Image

Climate change education

WTHI Events

 

Illinois Coronavirus Cases

(Widget updates once daily at 7 p.m. CT)

Cases: 1076532

Reported Deaths: 20153
CountyCasesDeaths
Cook4358889065
DuPage692851153
Will58408870
Lake53439886
Kane46063677
Winnebago26295407
Madison24398463
St. Clair22343426
McHenry21712248
Champaign15485102
Peoria15054241
Sangamon14548235
McLean13244159
Tazewell11944245
Rock Island11919303
Kankakee11488179
Kendall971578
LaSalle9478247
Macon8836179
Vermilion7538113
DeKalb749192
Adams7371117
Williamson6196116
Boone554977
Whiteside5261173
Clinton503285
Coles470380
Ogle460371
Knox4589142
Grundy438754
Effingham431169
Jackson418767
Henry401476
Marion3994112
Macoupin384994
Franklin384769
Randolph371568
Livingston364766
Monroe358770
Stephenson353274
Jefferson3435104
Morgan325989
Woodford320266
Logan309456
Montgomery305342
Lee304872
Bureau300484
Christian298673
Fayette291153
Perry267060
Iroquois259756
Fulton256949
Jersey222556
Lawrence217630
McDonough215051
Saline203053
Douglas199533
Union199332
Shelby197035
Crawford176134
Cass175131
Bond173824
Warren158644
Pike154346
Richland153644
Wayne152043
Hancock148634
Jo Daviess148524
Clark147730
Washington145225
Edgar144353
Carroll142633
Ford139049
Moultrie137428
White133430
Clay131240
Greene125742
Johnson121115
Wabash117914
Piatt117416
Mercer117229
Mason116640
De Witt114727
Cumberland108527
Jasper104015
Massac101831
Menard88010
Hamilton71717
Marshall67013
Schuyler62416
Pulaski6133
Brown61011
Stark49320
Edwards4629
Henderson45316
Calhoun4404
Alexander3897
Gallatin3884
Scott3851
Putnam3462
Hardin3038
Pope2472
Unassigned1050
Out of IL320

Indiana Coronavirus Cases

(Widget updates once daily at 8 p.m. ET)

Cases: 595436

Reported Deaths: 9466
CountyCasesDeaths
Marion822851311
Lake44626670
Allen32165543
Hamilton28684308
St. Joseph26917378
Elkhart24173343
Vanderburgh18856236
Tippecanoe17638125
Johnson14687289
Porter14513163
Hendricks14010242
Madison10715216
Vigo10540177
Clark10349135
Monroe9189108
Delaware8956134
LaPorte8867158
Howard7982140
Kosciusko791380
Warrick652994
Hancock646999
Bartholomew631096
Floyd6205107
Wayne5984159
Grant5874110
Dubois547175
Boone538867
Morgan524192
Henry497764
Marshall495384
Cass475362
Dearborn464545
Noble463157
Jackson417846
Shelby405680
Lawrence383876
Clinton367840
Gibson360058
DeKalb339163
Montgomery338152
Harrison333643
Knox329839
Miami312743
Steuben309343
Adams297435
Whitley297225
Wabash294947
Ripley294345
Putnam288047
Jasper285234
Huntington284959
White269138
Daviess263073
Jefferson253838
Decatur243482
Fayette242948
Greene237062
Posey234427
Wells231347
LaGrange225061
Clay219032
Scott218538
Randolph209845
Jennings193935
Sullivan189632
Spencer184319
Fountain180527
Washington179321
Starke172743
Jay163922
Fulton161130
Owen161137
Carroll153915
Orange152933
Rush151618
Perry149327
Vermillion145833
Franklin144433
Tipton129232
Parke12918
Pike114326
Blackford109222
Pulaski95337
Newton89821
Brown85931
Benton85310
Crawford7719
Martin70713
Warren6637
Switzerland6235
Union6146
Ohio4727
Unassigned0374