This update corrects Marie McCausland's last name spelling.
Marie McCausland found a baby boy, Jeffrey, on Mother's Day in 201
The very serious sincerity greatly contributed to a medical emergency. Four days later, McCausland was admitted to hospital for postpartum preeclampsia, a rare but serious condition that could cause seizures, stroke and other complications that threaten life.
McCausland, who is 28 and lives in Cleveland with her husband and son, returned to her work as an HIV researcher 10 weeks after she has been slow. But something was not right. She had a beautiful child who had her own blue eyes, but she was not good.
She felt exhausted and sad. She always felt guilty. She started a panic attack.
“I think you have postpartum depression,” said her husband.
Postpartum depression affects women from all nine of the United States, according to the Centers for Disease Control and Prevention. Symptoms include feeling sad or prickly, suicidal thoughts, inability to make pleasure in things that were enjoyable, unable to concentrate and change in sleep patterns. It is about worse nutrition and health in a newborn womb and can interfere with breastfeeding and connecting an infant's mother. It can happen during or after pregnancy.
McCausland did not think she had postpartum depression. She didn't feel isolated from her son; he liked it a bit. She was just tired from an incident and preeclampsia work, she argued for her husband.
But her past mood fell in the coming months, and after an incident in which she was hoping she was dead in her closet, she decided it was time to get help. It wasn't easy – although she could quickly see a psychiatrist quickly, it took more than a month to get an appointment with a therapist.
The Food and Drug Administration is expected to approve this treatment for postpartum depression, called brexanolone, this month. Developed by Sage Therapeutics Inc.
SAGE, + 2.18%
intended to market the drug under the name Zulresso, the first drug therapy allowed for specific treatment of postpartum depression.
Postpartum depression is usually managed through psychotherapy and antidepressant medication, recommended by McCausland psychiatrist. But these treatments may take weeks. In McCausland's case, it took a few months, she said.
Brexanolone, which is administered by intravenous infusion over 60 hours, is to start working within days.
The main component of the brexanolone injection is allopregnanolone, progesterone metabolite which connects to gamma-amino-amino acid receptors in the brain that have a role in mood control. The amount of allopregnanolone in the body increases during pregnancy and then it falls rapidly after childbirth
Results from two Phase 3 random trials of brexanolone published in The Lancet in September showed that the drug could significantly improve postpartum depression symptoms within days. Researchers looked at the effect of brexanolone on 246 women with moderate post-residue moderate depression. They used a survey called Hamilton Rating Scale for Depression (HAM-D) to estimate intensity – the higher the score, the more intense the depression.
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helps After 60 hours, HAM-D scores fell more in the brexanolone groups than in the placebo groups. The effects were permanent; 30 days later, the depression scores in the treatment groups were not back to the baseline and remained lower than those in the placebo groups.
“This is like anything we currently offer,” said Samantha Meltzer-Brody, a leading study author and director of Lancet on the perinatal psychiatric program at the University of North Carolina at Chapel Hill. “Now an opportunity to treat women quickly, within days.”
The side effects of the drug were headache, dizziness and drowsiness. One patient lost awareness during the infusion, but he got it off when the infusion was refused.
The drug is likely to cost $ 20,000 to $ 35,000 per treatment, according to Sage Chief Business Officer Michael Cloonan. The company is currently working with payers to resolve coverage characteristics and is looking at a launch date in June, he said.
Brexanolone may not be for everybody. The 60-hour infusion is likely to make the majority of severely diagnosed women requiring rapid relief, said Ruta Nonacs, a psychiatrist at the Ammon-Pinizzotto Center for Women's Mental Health in Massachusetts General Hospital. were involved in the trials. It may be difficult for some mothers to leave their families for the amount of time needed for treatment.
“Being in hospital for two or three days is a great disruption,” she said. However, brexanolone could be a “point of view” for mothers with severe depression or mothers who had not received a response to other treatments, Dr. Dr. Paul McAleese said. Nonacs. There is still an urgent need for drugs that can resolve depression symptoms more quickly than is currently available, she said.
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Researchers are working on it. Earlier this month, the FDA Johnson & Johnson approved
nasal spray acting fast for severe depression called esketamine, a close chemical relationship with cetamine. Sage is developing an oral drug with an activity mechanism similar to brexanolone to treat post-natal depression and a major serious disorder.
“We consider this to be a new mechanism not previously examined,” said Chief Executive, Sage Jeff Jonas.
“Zulresso has many ways, in many ways,” he said.