"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, a researcher involved in the drug's clinical trials and the director of Women's Behavioral Health at Zucker Hillside Hospital in Manhasset, New York.
Postpartum depression affects about 400,000 American women a year.
Postpartum depression often occurs following childbirth, but symptoms, including sadness, decreased ability to feel pleasure, cognitive impairment, feelings of worthlessness or suicidal ideation can start during pregnancy, says the FDA.
However, Farchione said Zulresso, also known as brexanolone, will not be available as an over-the-counter prescription right away.
Dr. Tiffany Farchione of FDA's Division of Psychiatry Products said in a statement that postpartum depression is quite a serious condition, which be life-threatening if it goes untreated. "Women may experience thoughts about harming themselves or harming their child, as well as hinder development of a maternal-infant bond", the press release reads.
In the study on new mothers with moderate to severe postpartum depression, Zulresso has been proven to be beneficial.
Time to recognise Golan Heights as Israeli territory Mr Netanyahu thanked Mr Trump for the Golan Heights gesture, telling the US President in a phone call he had "made history". The Syrian government vowed to recover the Israeli-occupied Golan Heights as its allies and enemies alike condemned U.S.
Up until Zulresso was approved, typical treatment options for PPD have been antidepressants.
It will be available beginning in June, though administration of the treatment will be restricted to the Zulresso risk evaluation and mitigation strategy program.
For this approval, the manufacturers presented the results of two clinical trials where Zulresso was found to be superior to placebo in improving the symptoms of postpartum depression after the first infusion dose.
Zulresso might cost up to $34,000 per patient, excluding the costs associated with several days stay in a medical center. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale.
Zulresso specifically targets postpartum depression as opposed to other types of depression because it contains a synthetic form of the hormone allopregnanolone, NBC reported.
"Women who had not wanted to eat or interact with others suddenly were smiling, interacting, becoming more social", Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina's Center for Women's Mood Disorders, told CTV News. "There's an enormous need for new, novel ways to treat depression, and to treat it quickly".
However, because of this rare side effect, the FDA has mandated that a boxed warning accompany the drug.
"I think many women who will be on this drug have to realize that they are going to be in a hospital for two-and-a-halfdays straight and be incapacitated", shesaid.
Microsoft says the company is working with Studio MDHR to integrate Xbox Live into the Nintendo Switch version of the game. Hopefully, this could also be the first in a long line of Xbox Live supported titles for Nintendo's console.
You can choose a VPN server region or let the app decide, and you don't have to leave the VPN on all the time. The VPN will allow users to connect to three broad geographic locations namely, Asia, Europe, and America.
The congressmen added that "President Trump's decision to break with this precedent raises the question of what he has to hide". A White House official confirmed to CNN that the White House has received the letter and is reviewing it.
The ministry said that Munasra was transferred to the Beit Jala Governmental Hospital, where he succumbed to his wounds. Palestinian security sources confirmed that more than 1,000 Israeli settlers had raided Joseph's Tomb via twenty buses.
Ricketts estimated that more than 2,000 homes and 340 businesses were damaged or destroyed by the flood, at a cost of $85 million. The Plains farm aid nonprofit Farm Rescue is launching an effort to bring donated hay to flood-stricken Nebraska ranchers.
The intense public interest in the onscreen death of Kit Harington's Game of Thrones character Jon Snow sent the actor to therapy. Less than a month away now from the premiere episode of HBO's hit fantasy series based off the novels written by George R.R.
Windows Central reports that it's received product images of the upcoming console, and has remade them as Photoshop mock-ups. Some more information and imagery has spilled with regard to the purported Xbox One S All-Digital Edition.
A ferry overloaded with people has capsized on the Tigris river near the Iraqi city of Mosul , killing more than 70 people. Video footage showed scores of people being carried away in the water's fast current as passengers on a nearby boat shout.
Qasemi also denied reports by Australian media in February that attempts to hack into the Australian parliament's computer network originated from Iran.
OR vs. Wisconsin in NCAA men's first round
They start four players who are listed at 6-9, including freshman forward and leading scorer Louis King (13.1 ppg). Despite outscoring Virginia in the second half, Wisconsin was limited to just 18 percent 3-point shooting.
Former cricketer Gautam Gambhir joins BJP
When asked if Gambhir would contest from a Lok Sabha seat in Delhi, Jaitley said let the party's election committee decide that. Former Cricketer Gautam Gambhir joined Bharatiya Janata Party ( BJP ) on Friday with weeks to go for the Lok Sabha elections.
NZ PM Jacinda Ardern receives death threats on social media
The national mourning and moment of silence were broadcast on television networks, radio and across multiple local media websites. Her father Elmi Abdukadir, 66, was killed - but five other members of her family managed to flee the mosque.
March Madness arrives: Round 1 of NCAA Tournament starts
They would have likely steamrolled us in the second round in their way to claim another Summit League Championship. As far as a Final Four representative I look for 2nd seed MI to advance but this region could be full of upsets.
Trump says public should see 'ridiculous' Mueller report
In that scenario, the AP reporters add, "the conservative media, including Fox News", will "act as an echo chamber". President Donald Trump talks to reporters as he departs on travel to OH from the White House, March 20, 2019.
Trump claims to have defeated ISIS caliphate in Syria, Iraq
The militants have been putting up a desperate fight, their notorious propaganda machine working even on the brink of collapse. The siege has also been slowed by the unexpectedly large number of civilians in Baghuz, a lot of them families of IS members.