Researchers wait for FDA approval for world's first postpartum depression pill

The first-ever medication designed exclusively for women suffering from postpartum depression is about to receive approval from health authorities.

Sage Therapeutics and Biogen, two Massachusetts-based pharmaceutical companies, announced on Monday that the FDA might approve the medication by August 6.

Patients only need to take the antidepressant medicine zuranolone for two weeks. This stands in stark contrast to Zulresso, the other medicine for postpartum depression (PPD) that is available but requires continuous IV infusions for 60 hours.

One in seven new mothers suffers from postpartum depression. Debilitating symptoms might range from intense dejection and excessive crying to thoughts of harming the infant, feeling distant from the infant, or believing the infant is someone else's.

Following the alleged murder of Lindsay Clancy's three children in Boston, Massachusetts, 32-year-old Clancy was diagnosed with an acute case of postpartum psychosis, which has garnered more attention recently.

Dr Priya Singhal, Biogen's Executive Vice president and head of research said on Monday: "We see the potential for zuranolone, if approved, to be a meaningful new option that can help address the serious unmet need faced by the diverse populations struggling with MDD (major depressive disorder) and PPD."

"The FDA filing acceptance and granting of priority review are important milestones in the mission Biogen and our collaboration partner Sage share to advance the understanding and treatment of depression," DailyMail quoted her as saying.

Zuranolone belongs to a group of medications that work by employing a compound known as a neurosteroid to target GABA receptors in the brain. It was created to help reset brain function by quickly rebalancing dysregulated brain networks in charge of activities like mood, arousal, behaviour, and cognition.

GABA and glutamate, two neurotransmitters, are thrown out of balance when a person is depressed, which affects neuron activity.

Although most antidepressant medications try to increase serotonin levels in the brain, mounting evidence suggests that the GABA pathway may be just as useful.

The pharmaceutical companies are requesting FDA approval based on the results of their two PPD trials and five MDD trials. Women who received the medication at a 50mg dose in the Phase 3 SKYLARK randomised research felt demonstrably better after three days.

Using the 17-item Hamilton Rating Scale for Depression (HAMD-17), they assessed PPD in women.

Scores between 0 and 7 are regarded as normal, while scores of 20 or more (which indicate at least moderate severity) are typically needed for enrollment in a clinical trial.

Women who had a major depressive episode that started in the third trimester or earlier than four weeks after giving birth and was fewer than six months postpartum were eligible to participate.

It's important to distinguish postpartum depression from the "baby blues," which are normal after giving birth and include mood swings, melancholy, and sobbing. It usually starts a few days after giving birth and lasts for a few weeks.

It's an uncommon disorder that often manifests within the first week following delivery. A new mother suffering from psychosis will view reality differently, interfering with their capacity to conduct themselves appropriately.

Treatment is available for postpartum psychosis, which frequently includes paranoia, abrupt mood swings, hallucinations, delusions, and suicidal or homicidal ideas.