On Tuesday, the agency announced the approval of brexanolone, a synthetic form of a hormone produced by progesterone in the brain.
Brexanolone is believed to help ease depression and anxiety by dampening neural activity, Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill, told The New York Times.
It was approved after clinical trials showed it was quickly effective in women who suffer crippling depression as new mothers.
One in 9 new mothers will suffer from postpartum depression, according to the Centers for Disease Control and Prevention.
"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, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, who was quoted in a press release.
Here’s what to know about Zulresso
- Name: Brexanolone (will be sold as Zulresso)
- How it is administered: The treatment is administered as a single 60-hour IV drip at a certified health care facility, according to the FDA
- Side effects: Headache, dizziness or excessive sleepiness; some have experienced a sudden loss of consciousness.
- Price: The drug will likely be priced between $20,000 to $35,000 per treatment, according to Sage Therapeutics, the company that developed the drug confirmed.
- How fast does it work: According to Sage, patients have seen an improvement in symptoms in as fast as 24 hours.
- When is it available: According to CNN, Sage Therapeutics said the drug will be available in June.
Symptoms of postpartum depression
From the Mayo Clinic, here is a list of symptoms of postpartum depression:
- Depressed mood or severe mood swings
- Excessive crying
- Difficulty bonding with your baby
- Withdrawing from family and friends
- Loss of appetite or eating much more than usual
- Inability to sleep (insomnia) or sleeping too much
- Overwhelming fatigue or loss of energy
- Reduced interest and pleasure in activities you used to enjoy
- Intense irritability and anger
- Fear that you're not a good mother
- Hopelessness
- Feelings of worthlessness, shame, guilt or inadequacy
- Diminished ability to think clearly, concentrate or make decisions
- Restlessness
- Severe anxiety and panic attacks
- Thoughts of harming yourself or your baby
- Recurrent thoughts of death or suicide
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