On March 19, a new type of antidepressant was approved, following the approval of esketamine by the FDA for the treatment of refractory depression on March 5. But different from the past, this drug is specially used to treat postpartum depression.
1. What is postpartum depression?
About 50% - 80% of pregnant women will experience postpartum depression, and 10% - 20% of pregnant women will progress to postpartum depression. Postpartum depression is the most common mental disease of pregnant women after delivery. It usually starts within 4 weeks after delivery. The symptoms and course criteria required for diagnosis are similar to other depression.
However, due to the special period of postpartum, women suffering from postpartum depression have a significant impact on their emotions, cognition, behavior, and functions, and are unable to take good care of their babies.
In addition, the proportion of postpartum depression patients with suicidal ideation and behavior is high. The most terrible thing is that some patients who are deeply involved in postpartum depression can't see the significance of their own survival, have strong suicidal ideas, and stubbornly believe that their children can't be taken care of when they die. Rather than leaving her/him to suffer in the world, they should also take her/him away. This kind of postpartum depression leads to extensive suicide incidents everywhere, and such human tragedies are staged every day.
2. How is postpartum depression generally treated?
For some mild postpartum depression, psychological treatment is generally chosen, such as interpersonal psychotherapy, cognitive behavior therapy, and family therapy. For some patients with severe disease, SSRIs are currently the first choice. In general, the concentration of antidepressants in milk is low. Common antidepressants usually take 2-4 weeks to take effect. Therefore, it will also affect the development of children. For example, fluoxetine can be secreted through milk.
The most headache for doctors in clinical practice is that patients worry that taking medicine may affect infants, and selective treatment will lead to further progress of the disease.
3. What drug is Zulresso?
Tetrahydroprogesterone has just been approved by the US FDA for the treatment of postpartum depression. Before that, there was no drug specifically used to treat postpartum depression.
From the pharmacological point of view, brexanolone powder is an allosteric regulator of the GABAA receptor, which can activate GABAA receptors inside and outside the synapse and produce antidepressant and anti-anxiety effects.
Clinically. ALLOPREGNAN-3ALPHA-OL-20-ONE can combine with the GABAA receptor, thus increasing the opening frequency of the chloride channel on the receptor, reducing the excitability of nerves, etc. It can inhibit HPA axis hyperactivity and promote neurogenesis.
4. Why can't 3-alpha,5-alpha-pregnanolone be made into medicine for use?
Allopregnanolone is mainly tetrahydro-progesterone, which is a neurosteroid with strong lipophilicity but poor water solubility. In addition, the oral bioavailability of tetrahydro-progesterone is poor and it will be rapidly metabolized.
Therefore, for the above problems. It can not be used orally. Only through slow and continuous administration can stable blood drug concentration be produced and a therapeutic effect is produced.
5. Why should I be hospitalized for treatment?
First of all, the drug needs to be used continuously for more than 60 hours and may have side effects such as excessive sedation and sudden loss of consciousness. It needs to be observed in the hospital and its blood oxygen level monitored at any time. Therefore, in consideration of its side effects and user mode, hospitalization is the safest way.
In addition, FDA requires manufacturers to conduct risk evaluation and mitigation strategy (REMS) management on the drug to ensure that the benefits of prescription drugs and biological products outweigh the risks.
Similarly, the previous approval of esketamine should also be subject to the management of REMS, and these drugs should be used reasonably under supervision.
6. What is the effect?
In 2017 and 2018, the Lancet magazine successively published the results of Zulresso's Phase II and III clinical trials.
In Phase II clinical practice, a total of 21 patients with postnatal depression were included. The patients were allocated to receive SAGE-547 and a placebo at a ratio of 1:1, and their depressive symptoms were evaluated at multiple time points after use.
The results showed that the depression symptoms of the experimental group treated with LJPC-0712 were significantly reduced after 1 day of use, and the effect could last until 1 month.
Phase II test results: It was found that Anlotinib Dihydrochloride could significantly reduce the depressive symptoms of patients one day after use, and the effect could last for another month
In the Phase III trial, more samples were included and more centers participated in the study. The study was divided into two parts to verify the results. The results also consistently suggest that 3α-OH-DHP can quickly relieve the depressive symptoms of postpartum depression patients.
7. What are the side effects?
Common side effects include headache, dizziness, drowsiness, pain at the injection site, nausea, dry mouth, and fatigue. Therefore, after receiving tetrahydro-progesterone treatment, the patient cannot drive a car, operate a machine, or perform other dangerous behaviors, unless the patient's tiredness completely subsides.
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