The results of the third and last phase of the experimentation of a are positive drug for postpartum depression.
The new therapy is based on the molecule zuranolone. It is a pill to be taken every day. Now the Food and Drug Administration is evaluating the results of this trial, assuring the priority review. The priority review means that the US drug agency will pay close attention to the data to give an answer as soon as possible.
If approved, the new drug for postpartum depression would revolutionize treatments
If approved this drug promises to revolutionize treatment for this clinical condition which can have very serious consequences. According to various American newspapers, the decision should arrive on August 5th. You can read the results of the study in the scientific journal American Journal of Psychiatry.
How does the new drug for postpartum depression work?
Zuranolone is the chemical synthesis of allopregnanolone, a substance naturally present in our bodies. It is a neuroactive steroid which is a metabolite of the hormone progesterone. Allopregnanolone levels they can increase significantly during pregnancy and then decrease sharply after delivery. This situation favors postpartum depression.
The role of hormones
These steroids are released in the brain and are its waste products progesterone. Their function is to protect brain networks from the harmful effects of stress and maintain healthy functioning of brain networks.
Therefore restoring allopregnanolone levels with structurally similar drugs such as zuranolone may help relieve symptoms of postpartum depression.
The trial of the new drug against postpartum depression
The researchers analyzed data from nearly 200 women suffering from severe postpartum depression. Experts have divided them into two groups. The former took the drug for 14 days, the latter a placebo. The group that took a 50-milligram dose of zuranolone each day for two weeks had significant improvements in depression symptoms compared to the group that took the placebo.
The researchers verified that this improvement started as early as three days after the start of the therapy and lasted at least 45 days.
What are the side effects?
The one with zuranolone it is a treatment for the acute phase, which lasts 14 days as mentioned. There are side effects, which are usually mild to moderate if you take the medication for the full two weeks.
26.5% had episodes of drowsiness, 13.3% dizziness, finally 11.2% sedation. A small fraction of the participants experienced headaches, diarrhea and nausea. None had particularly serious side effects.
Why is the new therapy better than the standard one?
The researchers pointed out that the benefits of zuranolone they are quick and the treatment can be done easily at home. Furthermore, for many patients, 14-day therapy and then close monitoring was sufficient to keep the situation at bay.
Currently, the treatments against postpartum depression involve taking standard antidepressants, which however require 12 weeks of therapy to see the first improvements