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First Drug for Postpartum Depression Has Been Approved in the United StatesThe new drug will be available in the U.S. starting June.by Lei Dimarucut-Sison .
The first drug to specifically treat postpartum depression (PPD) has been approved by the United States' Food and Drug Administration (FDA) after it showed the most promising effects on women diagnosed with severe depression.
According to The New York Times, the drug will provide immediate relief (it works within 48 hours) "for mothers whose depression keeps them from providing their babies with care, bonding and nurturing that is crucial for healthy development."
FDA gave the breakthrough drug called brexanolone a "breakthrough therapy designation" in 2016, which "is intended to expedite the development and review of drugs for serious or life-threatening conditions," the FDA website explains. Two clinical trials soon after ensued involving more than 200 women who were assessed to exhibit symptoms of postpartum depression.
"Brexanolone in phase II and III trials demonstrated rapid antidepressant effects," said Dr. Kristina Deligiannidis, one of the researchers at the clinical trials and the director of Women's Behavioral Health at Zucker Hillside Hospital in New York.ADVERTISEMENT - CONTINUE READING BELOW
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Brexanolone, which will be marketed under the brand Zulresso, which comes in the form of an intravenous (IV) infusion drip. Clinical trials have shown it to work within a few hours with minimal side effects such as dizziness, headaches, and sleepiness.
Results show that 75% of the women had an at least 50% improvement in their symptoms. Moreover, 94% of those who responded to the drug did not show a relapse at the follow-up conducted 30 days after.
Although it provides immediate relief, the drug needs to be administered in a single 60-hour session, "during which a new mother must remain in a certified medical center, under supervision should she get dizzy or faint, as several patients did in clinical trials," New York Times reports.
The new drug also comes with an expensive price tag. A vial of Zulresso will cost US$7,450 (almost Php400k), according to the manufacturer Sage Therapeutics, a biopharmaceutical company in the United States, and the actual number of vials needed for the treatment may vary per patient.ADVERTISEMENT - CONTINUE READING BELOW
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"Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.
Among the symptoms of PPD are insomnia, feelings of worthlessness or excessive inappropriate guilt, indecisiveness, and recurrent thoughts of death and suicidal thoughts.
Zulresso will be made available in June 2019 through a restricted distribution program called the Zulresso Risk Evaluation and Mitigation Strategy (REMS). It shall only be administered at certified health care facilities where the health care provider can carefully monitor the patient, the FDA says.