This update corrects the spelling of Marie McCausland’s last name.
Marie McCausland gave birth to a baby boy, Jeffrey, on Mother’s Day of 2017.
The joyous occasion was quickly marred by a serious medical emergency. Four days later, McCausland was admitted to the hospital for postpartum preeclampsia, a rare but serious condition that can lead to seizures, stroke and other life-threatening complications.
McCausland, who is 28 and lives in Cleveland with her husband and son, returned to her work as an HIV researcher 10 weeks after her ordeal. But something wasn’t right. She’d just had a beautiful baby who had her own blue eyes, but she didn’t feel good.
She felt exhausted and sad. She felt guilty all the time. She started having panic attacks.
“I think you have postpartum depression,” her husband told her.
Postpartum depression affects one in nine women in the U.S., according to the Centers for Disease Control and Prevention. Symptoms include feeling sad or tearful, suicidal thoughts, inability to take pleasure in things that were once pleasurable, inability to concentrate and a change in sleep patterns. It is associated with worse nutrition and health in the newborn and can interfere with breast-feeding and mother-infant bonding. It can happen during or after a pregnancy.
McCausland didn’t think she had postpartum depression. She didn’t feel detached from her son; she loved him to bits. She was just tired from the preeclampsia episode and work, she insisted to her husband.
But her mood spiraled downward over the next several months, and after an incident where she envisioned herself dead in her closet, she decided it was time to get help. It wasn’t easy — although she was able to see a psychiatrist fairly quickly, it took more than a month to get an appointment with a therapist.
A new treatment for postpartum depression, called brexanolone, was approved by the Food and Drug Administration on Tuesday. Developed by Sage Therapeutics Inc. SAGE, -0.50% which plans to market the drug under the name Zulresso, it is the first drug therapy approved to specifically treat postpartum depression. Shares of the company rose 2% in premarket trade Wednesday after the announcement.
Postpartum depression is typically managed through psychotherapy and antidepressant medications, which is what McCausland’s psychiatrist recommended to her. But those treatments can take weeks to take effect. In McCausland’s case, it took a couple of months, she said.
Brexanolone, which is administered by intravenous infusion over 60 hours, is supposed to start working within days.
The main component of the brexanolone injection is allopregnanolone, a progesterone metabolite that binds to gamma-aminobutyric acid receptors in the brain which play a role in regulating mood. The amount of allopregnanolone in the body increases during pregnancy and then falls rapidly after childbirth.
Results from two randomized Phase 3 trials of brexanolone published in The Lancet in September showed the drug could significantly improve postpartum depression symptoms within days. Researchers looked at the effect of brexanolone on 246 women with moderate to severe postpartum depression. They used a survey called the Hamilton Rating Scale for Depression (HAM-D) to evaluate severity — the higher the score, the more severe the depression.
After 60 hours, HAM-D scores fell more in the brexanolone groups than in the placebo groups. The effects were long-lasting; 30 days later, the depression scores in the treatment groups had not returned to baseline and remained lower than those in the placebo groups.
“This is unlike anything we currently have available,” said Samantha Meltzer-Brody, the lead author of the Lancet study and director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill. “We now an opportunity to treat women quickly, within days.”
The main side effects of the drug were headache, dizziness and sleepiness. One patient lost consciousness during the infusion, but regained it when the infusion was turned down.
The drug will be priced at $20,000 to $35,000 per treatment, according to Sage Chief Business Officer Michael Cloonan. The company is still working with payers to iron out coverage specifics and is looking at a launch date sometime in June, he said.
Brexanolone may not be for everybody. The 60-hour infusion will probably appeal most to women with severe symptoms who need rapid relief, said Ruta Nonacs, a psychiatrist at the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital who was not involved in the trials. Some mothers might also find it difficult to leave their families for the amount of time required for treatment.
“It’s a pretty big disruption to be hospitalized for two or three days,” she said.
Nevertheless, brexanolone could be a “godsend” to mothers who have severe depression or mothers who haven’t responded to other treatments, said Dr. Nonacs. There is still an urgent need for drugs that can resolve depressive symptoms more quickly than what’s currently available, she said.
Researchers are working on it. Earlier this month, the FDA approved Johnson & Johnson’s JNJ, +0.93% fast-acting nasal spray for severe depression called esketamine, a close chemical relation to ketamine. Sage is developing an oral drug with a similar mechanism of action as brexanolone for the treatment of both postpartum depression and major depressive disorder.
“We think this is a novel mechanism that’s not been explored before,” said Sage Chief Executive Jeff Jonas.
“Zulresso is, in many ways, just the tip of the spear,” he said.
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