Posted by SLS on October 10, 2023, at 9:21:54
"Deemed"
The FDA was about to approve zuranalone for Major Depressive Disorder, when a clinical study reported that the trial failed to meet the requirements to be deemed effective. There are more independent investigations reporting the efficacy of zuranolone than there are reporting failure.
Zuranolone is already approved for PPD. It's pharmacology is novel as an antidepressant. It is hard to justify not prescribing it off-label if a patient has been refractory to all other treatments. I haven't seen any concerns regarding dangerous side effects. Of course, I haven't been exposed to all of the information available.
Anyway, it is potentially one more tool in the toolbox. Just as psilocybin (microdoses?) is, despite not being approved by the FDA.
I've written at length several times in the past that the paradigm for clinical trials as they have been performed over the last 25 years has sabotaged the pharmacopeia of psychiatric drugs. I don't doubt that the zuranolone clinical trials are equally flawed. Have you ever wondered why the placebo response rate has doubled since the 1980s, while the response to active compound has gone down? In a nutshell, this is the consequence poor selection criteria or not enforcing a good one. As a consequence, I don't pay attention to failed clinical trial anymore.
- Scott
Some see things as they are and ask why.
I dream of things that never were and ask why not.The only thing necessary for the triumph of evil is that good men do nothing.
poster:SLS
thread:1122241
URL: http://www.dr-bob.org/babble/20230117/msgs/1122241.html