The first medication for postpartum depression has been approved in the US.
The Food and Drug Administration (FDA) declared that zuranolone, marketed under the trade name Zurzuvae, has been approved as a once-daily pill taken for two weeks.
According to the FDA, there has only ever been one method of treatment for postpartum depression (PPD): intravenous injection.
The pill is anticipated to go on sale later this year, according to drug manufacturers Sage Therapeutics and Biogen. The cost has not yet been revealed.
According to the FDA, postpartum depression (PPD) symptoms can include sadness, a lack of energy, suicidal thoughts, a diminished capacity for pleasure, or cognitive impairment.
Research has found that, one in seven women in the US are thought to have PPD symptoms.
The head of psychiatry at the FDA’s Center for Drug Evaluation and Research, Tiffany Farchione, described postpartum depression as “a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child.”
“And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.”
For many women “coping with extreme, and sometimes life-threatening, feelings”, having access to an oral medication will be beneficial, she added.
The medication significantly reduced depressive symptoms within three days, according to clinical trials. The effect of the medication was maintained at four weeks after the last dose, the FDA said.
The most frequent adverse reactions from taking Zurzuvae were listed as being drowsiness, dizziness, diarrhea, fatigue, the common cold, and urinary tract infection.
The organization said Zurzuvae’s boxed warning on the labeling mentions how it may impair a person’s ability to drive and engage in other potentially dangerous activities. For at least 12 hours following administration, it is advised that patients refrain from operating heavy machinery or driving.
The use of zuranolone for major depressive disorder (MDD), also known as clinical depression, was also sought after by Sage Therapeutics and Biogen. The FDA, on the other hand, stated that more studies would be required because the medication did not offer convincing proof of its efficacy.
The companies said they were evaluating their next steps.
Sage Therapeutic expressed its “highly disappointed for patients, particularly amid the current mental health crisis and millions of people with MDD struggling to find symptom relief.”
Source-BBC
