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Re: NDA Submitted for Postpartum Depression Drug

Posted by SLS on April 25, 2018, at 12:28:58

In reply to Re: NDA Submitted for Postpartum Depression Drug, posted by Hugh on April 25, 2018, at 9:57:49

> Sage Therapeutics is testing an oral drug similar to brexanolone to treat major depressive disorder, postpartum depression, essential tremor, Parkinson's, and insomnia. Here's a description of it from Sage's website:
>
> "SAGE-217 is a novel, selective, next generation GABAA positive allosteric modulator that shares similar pharmacology properties to brexanolone. We are initially developing SAGE-217 as a once-daily, oral therapy for treatment of various CNS disorders."
>
> The phase 2 clinical trial results for SAGE-217 for major depressive disorder were released late last year.
>
> "At day 15, 64% of patients in the treatment group achieved remission compared to 23% for placebo (p=0.0005). Other secondary endpoints were also met."

That sounds great. I'll be curious to see how they choose subjects for phase three trials. My guess is that when diagnostic inclusion criteria for depression are followed strictly, better numbers emerge for treatment response. From the 1960s through the early 1980s, the response rates to antidepressants were reported to be about 65%. That is much better than placebo response.


- Scott


Some see things as they are and ask why.
I dream of things that never were and ask why not.

- George Bernard Shaw

 

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