Symptoms of PPD include anxiety, mood swings, changes in appetite, excessive irritability, sadness, fear of not being a good mother and misery.
Postpartum depression has historically been treated with counseling or general antidepressants, which can take weeks to kick in or may not work at all. It can be especially devastating because it can cause fear or thoughts of wanting to harm your baby.
"Not only do we believe Zulresso will address an important need for women's mental health, the impact of PPD is multi-generational, and we look forward to bringing Zulresso to patients in urgent need of a new treatment option".
The newly-approved drug is brexanolone. Zulresso also begins to work in about three days, much faster than other antidepressant treatments.Читайте также: Sugary Drinks Might Be Linked to An Increased Risk of Early Death
Dr. Kimberly Yonkers, professor of psychiatry, epidemiology and obstetrics, gynecology, and reproductive sciences at the Yale School of Medicine, agreed that getting mothers to open up about their struggles will have an even larger effect on postpartum depression research.
Deligiannidis said the drug was largely safe, with headache (about 16 percent of patients), dizziness (about 14 percent) and sleepiness (nearly 11 percent) being the most common side effects. This requires the drug be administered by a health care provider in a certified health care facility.
In both placebo-controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion, the US Food and Drug Administration noted, adding that the improvement in depression was also seen at the end of the 30-day follow-up period. You must stay in the treatment facility for that entire time and your blood oxygen levels will be constantly monitored for safety. The pill, now known as SAGE-217, is produced from a comparable molecule to the particle used in Zulresso, the Times said.
The treatment is expected to be available starting in June after the U.S. Drug Enforcement Administration schedules the drug, which will happen within about 90 days.
USA media say the treatment will cost $34,000 a year for people without health insurance. However, many are still optimistic Zulresso will make a big difference in many women's lives.
Sage submitted its New Drug Application in May 2018 based on data from two Phase III clinical trials in patients with severe postpartum depression and moderate postpartum depression. It is the first drug approved by the FDA specifically for PPD, Xinhua quoted a FDA release as saying.При любом использовании материалов сайта и дочерних проектов, гиперссылка на обязательна.
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