[HN Gopher] FDA Approves First Oral Treatment for Postpartum Dep...
___________________________________________________________________
FDA Approves First Oral Treatment for Postpartum Depression
Author : gmays
Score : 21 points
Date : 2023-08-08 20:45 UTC (2 hours ago)
(HTM) web link (www.fda.gov)
(TXT) w3m dump (www.fda.gov)
| pessimizer wrote:
| > The primary endpoint of both studies was the change in
| depressive symptoms using the total score from the 17-item
| Hamilton depression rating scale (HAMD-17), measured at day 15.
| Patients in the Zurzuvae groups showed significantly more
| improvement in their symptoms compared to those in the placebo
| groups.
|
| Why would you mention the number of items on the scale, but not
| mention the number of points the drug gained? Is it that
| professionals normally refer to it as the "17-item Hamilton
| depression rating scale"?
|
| That they're mentioning the number of points in the scale, but
| not the number of points gained, makes me wonder if this barely
| limped into significance under the most favorable conditions.
| duskwuff wrote:
| > Why would you mention the number of items on the scale, but
| not mention the number of points the drug gained? Is it that
| professionals normally refer to it as the "17-item Hamilton
| depression rating scale"?
|
| Correct. "17-item Hamilton depression rating scale" (or
| HAMD-17) is the precise name of the scale; "17-item" is
| required to distinguish it from other variations with different
| numbers of questions.
|
| The precise improvement in scoring is undoubtedly present in
| the clinical trial paper, but isn't relevant to a FDA press
| release about their approval of the drug.
|
| https://dcf.psychiatry.ufl.edu/files/2011/05/HAMILTON-DEPRES...
| ellisv wrote:
| > The precise improvement in scoring is undoubtedly present
| in the clinical trial paper, but isn't relevant to a FDA
| press release about their approval of the drug.
|
| Exactly. If it isn't harmful, it doesn't have to be very
| helpful -- the effect can be small and significant.
| ellisv wrote:
| Looks like about 4 points.
|
| [1]
| https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/21...
| anonymousiam wrote:
| [flagged]
| otachack wrote:
| Too late for countless families if you gather all the
| historical data. That doesn't mean we shouldn't try to curb
| this.
| 01100011 wrote:
| https://en.wikipedia.org/wiki/Zuranolone
|
| "An orally active inhibitory pregnane neurosteroid, zuranolone
| acts as a positive allosteric modulator of the GABAA receptor."
|
| Interesting. I was expecting another SSRI or something similar.
| rabbits_2002 wrote:
| "positive allosteric modulator of the GABAA receptor", isn't
| that a benzodiazepine?
|
| edit: nevermind i guess drugs are classified by their chemistry
| rather than their effects
| trehalose wrote:
| Drugs can be variously classified by their chemistry and/or
| by their effects. It's worth noting that GABA-A receptors
| have multiple allosteric sites, and different chemical
| classes of PAMs (positive allosteric modulators) may have
| differences in effects. (There certainly seems to be
| substantial overlap in effects, of course.)
___________________________________________________________________
(page generated 2023-08-08 23:00 UTC)