Saturday , July 20 2019
Home / canada / The FDA approves the first drug targeted at the treatment of postpartum depression

The FDA approves the first drug targeted at the treatment of postpartum depression

U.S. The Food and Drug Administration has approved a drug designed to specifically treat postpartum depression in mothers, a first for the agency.

The FDA announced in a press release Tuesday that it approved an intravenous infusion of brexanolone, a drug labeled as Zulresso. Patients would receive continuous IV drops over 60 hours. The news message said clinical tests, involving more than 200 women, brexanolone showed work within hours to help treat postpartum depression, which affects 1 out of 9 new mothers.

Postpartum depression is much harder and longer than "baby blues", many new mothers experience about a week after they were born. Symptoms of postpartum depression may include grief, loss of interest, difficulty in tying with the child and even suicidal thoughts.

"Postpartum depression is a serious condition that, when difficult, can be life-threatening. Women may experience thoughts of harming or damaging their child. Postpartum depression can also interfere with maternal childhood," said Dr. Tiffany Farchione, acting director of Division of Psychiatry. Products in the FDA's Center for Drug Evaluation and Research. "This approval marks the first time a drug has been specifically approved for the treatment of postpartum depression, providing an important new treatment option."

Zulresso will only be provided through a REMS (Risk Evaluation and Reduction Strategy) program that requires a healthcare provider to administer the drug in a certified healthcare service. Farchione said that the REMS program is necessary "because of concern about serious risks, including excessive sedation or sudden unconsciousness during administration."

So far, the only treatment options for people with postpartum depression have included counseling or talk therapy and antidepressant drugs that are not specifically FDA-approved to help new postpartum depression mothers. according to the National Institute of Mental Health.

The 60-hour duration of treatment can make it difficult for some new mothers to participate. It is all about sedation, and the patients must be accompanied when they interact with their children during the infusion according to the release. This is in addition to the processing cost, which CNN said is likely to be $ 20,000 to $ 35,000 per treatment, according to Sage Therapeutics, the biopharmaceutical company that created the treatment. Mothers without extra home support and low income mothers are often particularly prone to postpartum depression.

Sage Therapeutics also advised that patients talk to their doctor about breastfeeding because the drug will pass into breast milk.

The treatment is is expected to be available from June after U.S. Drug Enforcement Administration plans the drug, which will happen within about 90 days.

Source link