First drug approved for treatment of post-partum depression
In a recent breakthrough, the Food and Drug Administration (FDA) approved the first drug for the treatment of post-partum depression (PPD). The new drug, brexanolone, will be manufactured by Sage Therapeutics, Inc. and will be marketed under the name Zulresso. This is likely to open floodgates to treatment addressing this debilitating concern which is one of the most common complications post pregnancy.
Interestingly, the drug acts very quickly, usually within 48 hours of administration, which is a marked improvement over the currently approved drugs for the disorder which can take anywhere between 2 to 4 weeks to exert action. Post-partum depression is a widely prevalent problem in the U.S. with 1 in 7 women battling this mental disorder. According to experts, this new treatment is likely to provide respite to new mothers who struggle to care for their babies and establish a strong bond with them which is crucial for their healthy upbringing.
Speaking about the approval, Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation and Research, stated that post-partum depression is a severe and incapacitating disorder which can become life-threatening. This approval is historical since it is the first time that a drug has been dedicated for the treatment of PPD.
New drug has its own challenges
Zulresso has been approved under the Risk Evaluation and Mitigation Strategy and will be available to patients under the restricted distribution program. It will be administered via a continuous infusion for a period of 60 hours during which a new mother would have to stay in a certified medical clinic under the supervision of skilled professionals as some patients were observed to feel dizzy or faint during the clinical trials. Sage shared that the infusion will be expensive costing a patient $34,000 before discounts. This excludes the cost of staying in a medical center for 2.5 days. The insurers are expected to cover the treatment, according to the company officials. However, when the insurers were contacted, they shared that the drug is being evaluated.
According to Sage, a pill or a tablet made with similar molecule is also being tested and has shown positive outcomes in clinical trials. A pill is more accessible and easier for use for patients. The company expects to submit the same for approval in some years if the results are promising. Along with the infusion which is to be administered only once, a patient might also be on the standard antidepressant therapy. The clinical trials have shown a sudden decrease in the symptoms of women struggling with moderate to severe depression compared to a similar placebo infusion.
Drug has a rapid effect
The clinical trial suggested that the symptoms of depression continued to decrease for a month post the infusion. While there were anecdotal reports sharing that the effect lasted for over a month in some women, there is a lack of research on long-term outcomes. The candidates for the treatment would most likely be women suffering from severe depression or who are resistant to standard antidepressants.
Despite the need to get admitted and the high expense, patients might consider this treatment as viable as PPD can prove to be incapacitating. The trials comprised 247 women selected randomly to receive the drug or a placebo. Even though the number of participants were quite small compared to other clinical trials, the results were persuasive enough for the FDA to grant an approval.
Seeking treatment for depression
Post-partum depression can seriously affect the mother-infant bond. If left untreated, it can lead to suicide ideation and thoughts about harming the baby and self. This can be conquered by following self-care tips and having a support system. However, if the symptoms are severe, one must seek professional help.
If you or a loved one is battling any kind of mental illness, feel free to reach out to us at Arizona Depression Helpline. Call our 24/7 helpline 866-233-3895 for more information about symptoms of depression in women and treatment options. You can also chat online with a representative to understand the best available option for different types of depression disorders.