2023-08-05 14:59:31
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Article informationAuthor, Oaf WalshRole, BBC News5 August 2023, 14:56 GMT
Last updated 10 minutes ago
The United States has approved the first pill to treat postpartum depression.
The US Food and Drug Administration (FDA) said that Zoranolone, which is sold under the brand name Zorzophy, has been approved as a once-daily drug for two weeks.
She explained that until now, treatment for postpartum depression was only available by intravenous injection.
The drugmakers Sage Therapeutics and Biogen said the pill is expected to be available later this year. Its price has not been announced.
Similar to other forms of depression, symptoms of postpartum depression can include sadness, loss of energy, suicidal thoughts, decreased ability to feel pleasure or cognitive impairment, according to the Food and Drug Administration.
A study found that one in seven women in the United States suffer from symptoms of postpartum depression.
“Postpartum depression is a serious and life-threatening condition in which women experience grief, guilt, worthlessness, and thoughts of harming themselves and their babies in severe cases,” said Tiffany Farchioni, chief of psychiatry in the FDA’s Center for Drug Evaluation and Research.
“Because postpartum depression can disrupt the mother-infant bond, it may also have consequences for the physical and emotional development of the child,” Varchioni said.
She added that access to oral medication would be beneficial for many women “to deal with intense, sometimes life-threatening emotions”.
Clinical trials showed that the pill significantly helped reduce symptoms of depression within three days. The FDI said the drug’s effect remained four weeks following the last dose.
She indicated that the most common side effects when taking Zorzovi can include drowsiness, dizziness, diarrhea, fatigue, colds and urinary tract infection.
The agency said the instructions for use of the new pill contain a warning that Xorzovy can affect a person’s ability to drive a vehicle and perform other potentially dangerous activities. Patients are advised not to drive or operate heavy machinery for at least 12 hours following taking the pill.
Sage Therapeutics and Biogen have also sought approval to use zuranolone to treat major depressive disorder, or clinical depression. Despite this, the “FDA” said that the drug did not provide substantial evidence of effectiveness, and said that additional studies were needed.
Both companies said they were considering their next steps.
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