Anna Elzabeth Tom, Correspondent, India Pharma Outlook
In 2019, the first breakthrough in Postpartum Depression (PPD) happened when the FDA approved brexanolone, sold as Zulresso; the first-ever drug developed specifically for postpartum depression. It is a chemically identical formulation of allopregnanolone itself, thus restoring the lost hormone and providing relief much faster in about 48 hours post medication.
But this quick relief comes at a very high price. It is administered as a continuous intravenous infusion for 60-hours at a certified healthcare facility. The patient is continuously monitored throughout the entire process due to the risk of serious side effects like sedation, vertigo, and sudden loss of consciousness. It might also lead to hypoxia (oxygen deficiency).To avail the medication; the patient should be enrolled in the Risk Evaluation and Mitigation Strategy (REMS) program.
Women who received it reported that they started to feel like themselves within a few days. It was a historic moment, because for the first time, women with postpartum depression were feeling better in days and not in weeks.
But here’s the reality check: a single vial of brexanolone costs roughly around USD 7,450, and an average treatment requires around four and a half vials, thus raising just the cost of medication to around USD 30,000 to 34,000. For an average Indian woman, just spending 28 to 30 lakhs for a depression just feels out of reach. And moreover, this medication is only available in the United States under a restricted programme in a specialized facility. The medicine is not available for routine clinical use in India. So for the vast majority of global women, this medicine is still out of their reach.
On August 4, 2023, came the next great leap for postpartum depression, Biogen’s zuranolone, branded Zurzuvae was approved by the U.S. Food and Drug Administration. On the occasion of approval of the medicine, Priya Singhal, Head of development, Biogen remarked “This approval is a major milestone in addressing a critical unmet need in maternal health for women in Europe, where postpartum depression is underdiagnosed and undertreated.”
Zuranolone works using the same neurosteroid mechanism as brexanolone. But, unlike brexanolone it’s in the form of a capsule that can be orally taken. The recommended dose for Zuezuvae is 50mg per day, and it has to be taken for a period of 14 days in the evening following a fatty meal. This was a ray of hope for many women. Now, they could take the medicine from their homes without getting hospitalized and needing an IV Line.
But again, this is not widely available in India via local pharmaceutical companies. One require a specialized named-patient import to access the medicine and it costs around Rs11,000 to Rs 22,000 and above for a pack of 14 capsules excluding import permit charges.
Things are getting better, but the work is far from over. These medicines are not safe for everyone and they remain inaccessible to most women around the world. To make the benefit reach the women who need it the most a lot of effort needs to be done on cost, infrastructure and creating awareness. The greatest gift we can give our mothers is not just love, but the certainty that they will not be left alone.