For the first time in history, the FDA has approved a treatment specifically for adult women experiencing postpartum depression (PPD).
Up until now, postpartum treatments have only consisted of mental health counseling, therapy, and standard antidepressants, many of which can take weeks – even months – to take effect.
Now, this newly-approved drug, which is being sold by Sage Therapeutics under the brand name Zulresso, was shown to relieve depressive symptoms within hours of being administered in three different clinical trials – and it continued to show success throughout their 30-day followups.
Though the treatment can only be administered via a 60-hour long IV drip session in a clinical setting, researchers are saying that the historic new treatment promises to help thousands of mothers.
Dr. Samantha Meltzer Brody, director of the Perinatal Psychiatry Program at the UNC Center for Women’s Mood Disorders and primary investigator of the Zulresso clinical trials, hailed the drug as “a game-changing approach to treating PPD.”
“The potential to rapidly reduce symptoms in this critical disorder is an exciting milestone in women’s mental health,” said Brody. “PPD is recognized to have a significant and long-term impact on women and their families, but with Zulresso we may finally have the opportunity to change that.”
Postpartum depression is the most common medical complication of childbirth, affecting approximately one in nine women who have given birth in the U.S. and 400,000 women annually. Though the condition is a distinct and readily identified major depressive disorder that can occur during pregnancy and after giving birth, more than half of these cases can go undiagnosed without proper screening.
Symptoms can last for months, sometimes even years after pregnancy, which can have devastating consequences for a woman and for her family, some of which may include significant functional impairment, depressed mood, loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. Additionally, suicide is the leading cause of maternal death following childbirth.
This week’s FDA approval of Zulresso is based on findings from three multi-center, randomized, double-blind, parallel-group, placebo-controlled trials, designed to evaluate the safety and effectiveness of Zulresso in women with moderate and severe PPD, aged between 18 and 45 years who were both 6 months postpartum or less at the time of screening and had onset of symptoms no earlier than the third trimester and no later than the first four weeks following delivery.
The trials were conducted across 30 different US research clinics between 2017 and 2018, and the results were published in The Lancet in August.
In all trials at all doses, Zulresso achieved the primary endpoint, which was a significant mean reduction in commonly used depression measurement scales, at 60 hours compared to placebo. A reduction of depressive symptoms was also seen as early as 24 hours, and Zulresso maintained effect through the 30-day follow-up. The most common adverse side effects in the studies were sleepiness, dry mouth, loss of consciousness, and flushing.
Stephanie Hathaway, a mother-of-two who was a participant in the drug trials, told CNN that she opted for the treatment after her mental health took an ominous turn following the birth of her second child – and she noticed an immediate change in her mood.
“It was a 60-hour infusion and in the first 12 to 18 hours I felt the biggest difference,” said Hathaway. “The first two weeks [after pregnancy] I was crying excessively … after that, I had intrusive thoughts. Those were, ‘Your daughter deserves a better mom,’ and ‘Your husband deserves a better wife.’
“Those intrusive thoughts that played on repeat in my head, those went away and didn’t come back.”
According to Jeff Jonas, chief executive officer of Sage Therapeutics, the treatment is set to be available to the public in June—but at a very expensive price point, tens of thousands of dollars.
“We believe Zulresso will address an important need for women’s mental health,” said Jonas. “Zulresso will be a catalyst in starting a new dialogue emphasizing the importance of women’s mental health, and the importance of diagnosing and treating PPD.”
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