First pill for postpartum depression could be rolled out in US by AUGUST 

Health chiefs are poised to approve the first-ever pill made specifically for women dealing with post-partum depression. 

Massachusetts-based drugmakers Sage Therapeutics and Biogen said Monday the Food and Drug Administration (FDA) could approve the medication by August 6.

The medication zuranolone is an antidepressant drug that patients only need to take for two weeks. This is a stark contrast to the other medication on the market for postpartum depression (PPD), a drug called Zulresso, which needs to be administered via IV continuously for 60 hours.

Postpartum depression plagues about one in seven new mothers. Symptoms can be debilitating, from deep despair and frequent crying to thoughts of hurting the baby, not feeling connected to the baby, or feeling as if your baby is someone else’s.

Increased focus has been put on the condition in recent weeks after Boston mother Lindsay Clancy, 32, allegedly murdered her three children after suffering from an extreme form of postpartum psychosis.

Postpartum depression is common- about one in seven new mothers experience it. And it can be treated with medications and talk therapy. 

Dr Priya Singhal, Biogen’s Executive Vice president and head of research said on Monday: ‘We see 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 [major depressive disorder] MDD 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.’

Zuranolone is one in a class of drugs that target GABA receptors in the brain using a substance called a neurosteroid. 

It was designed to rapidly rebalance dysregulated brain networks responsible for functions such as mood, arousal, behavior, and cognition, to help reset brain function.

When a person is depressed, GABA and glutamate, both neurotransmitters, are thrown out of balance, affecting neuron activity. 

Depression treatments typically aim to boost serotonin levels in the brain, but a growing body of research shows that the GABA pathway may be just as effective.

The drug companies are seeking FDA approval on the strength of their five trials in MDD and two trials in PPD. In the Phase 3 SKYLARK randomized study, women receiving the drug at a 50mg dose felt measurably better after three days.

They measured women with PPD based on the 17-item Hamilton Rating Scale for Depression (HAMD-17). 

A score of zero to seven is considered to be normal, while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial. 

Women were enrolled if they were less than six months postpartum and had a major depressive episode beginning during the third trimester or before four weeks postpartum.

Women who received zuranolone each evening for two weeks experienced a greater reduction in HAMD scores than women receiving a placebo pill. 

At day 15, the mean reduction in HAMD scores was 15.6 in women receiving zuranolone vs. 11.6 in the placebo group.

At day 45, women treated with zuranolone continued to show a greater reduction in HAMD scores than women receiving a placebo (down 17.9 points and 14.4 points, respectively).

Dr Laura Gault, Chief Medical Officer at Sage said: ‘We feel a tremendous responsibility to patients with MDD and PPD to deliver a potential new treatment option, which is so desperately needed. Most current approved therapies may take weeks or months to work. We are committed to advancing treatments that could help physicians and patients by addressing depression symptoms quickly.’

Postpartum depression should not be mistaken with the ‘baby blues,’ a common occurrence after giving birth characterized by mood swings, depression, and crying. It typically comes on a couple of days after giving birth and can last a couple of weeks.

Lindsay Clancy, 32, is accused of killing her daughter Cora, 5 and son Dawson, 3, at the family home in Massachusetts and attacking baby Callan, who is eight months old. Pictured L-R: Lindsay, Dawson, Corey and husband Patrick 

In more extreme cases, a new mother may experience postpartum psychosis, the condition that Ms Clancy is believed to have had when she committed the murders.

It’s a rare condition that usually develops within the first week after delivery. A new mother with psychosis will have an altered experience of reality which interferes with their ability to function normally.

Postpartum psychosis, which tends to include paranoia, dramatic mood changes, hallucinations, delusions, and suicidal and/or homicidal thoughts is treatable. 

Mental health professionals have a full army of antidepressant drugs at their disposal. The medication does not have to be tailored to PPD symptoms to work. Talk therapy is also a useful tool for millions of women struggling post-pregnancy.