Sage Therapeutics is readying a new treatment (Brexanolone IV) for postpartum depression — a condition that affects 10-20% of new mothers and is one of the most horrific things anyone can go through.
The treatment is so novel and effective that the FDA rewarded it with a breakthrough therapy designation and it hopes to be on the market in 2019. It would be the first drug (it’s actually an infusion!) specifically designed to treat PPD.
The company’s CEO explains a little bit more on Jim Cramer’s show.
“This is an intravenous treatment called Brexanolone. You’re talking about 400,000+ U.S. women alone who get this diagnosis. It’s one of the leading causes of maternal death, after childbirth, and there are no approved therapies.
…. we’ve done three controlled trials. In almost all of them, we’ve got a 70% remission rate after 2.5 days of treatment.”
….conventional therapies are SSRI’s…. you get on that drug, you wait often 6-8 weeks, or maybe on it chronically…. our approach is the idea of getting a rapid, robust and durable response, and the idea that if you can get better in 2.5 days — if you can achieve that, why would you wait 6-8 weeks?”
Sounds remarkable –70% remission rate! Imagine the lives and families that could be saved.
Here’s a little bit more info…. It requires a 60 hour infusion at the hospital, and in phase 3 results, both women with severe and moderate postpartum depression found significant reduction in symptoms compared to a placebo group.
Among the group with severe PPD, positive effects were seen at 48 hours and at 60 hours, and the effects were sustained for at least 30 days.
It was well-tolerated with only three adverse events that led to discontinuation.
As for the science of it?
Brexanolone (SAGE-547) is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor.
The big question is whether insurance will cover the treatment, because currently the infusion must be given at the hospital. That’s why SAGE is now testing a pill.
Of course, critics of the drug industry will say this is just another cash-grab scheme, but if you’ve ever known someone who’s gone through PPD, please remember this is a condition that leads many new mothers to suicide, destroying homes forever.
If this treatment truly leads to a 70% remission rate in mothers with severe PPD, hey, I don’t care if Sage Therapeutics makes some money from it. Let’s just hope insurance companies recognize the value of addressing the problem at its source.
Exciting news.
Depression should be treated like a broken leg or a seizure, says CEO of development-stage biotech Sage Therapeutics from CNBC.
