MDMA (ecstasy) and Vagus Nerve Stimulation hit road blocks on the treatment development pathway.
. This vote came in spite of the fact that there are two phase 3 studies that were ‘positive’ seem quite good.
It’s worth noting that the panel’s recommendations are non-binding. In other words, the FDA can technically move forward and approve MDMA . But my bets are against approval .There’s a lot of speculating as to why the panel voted this way. I think a big part of this is the growing alarm in psychiatry about a runaway train that may cause great societal harm.
), that psychedelic substances should be legal for all and that FDA approval is just one step on the path to that goal do not assuage regulators’ concerns. All of this is to say that there is worry about further opening Pandora’s box when it comes to approving for wider use substances that could have serious adverse safety profiles. I’m not saying this is right or fair , but I think it’s playing into the. VNS is a therapy where a small device is implanted into the body near the shoulder, with a wire that frequently stimulates the vagus nerve near the neck.
The news that the RECOVER trial did not meet its primary outcome is disappointing. The company reports that there was evidence of “clinically meaningful benefits in select secondary endpoints.” The wrinkle here is that, unlike most circumstances, the RECOVER trial is not meant to convince FDA regulators but to convince topat CMS to pay for the treatment. It will be interesting to see how this unfolds. Hopefully, more details of the trial results will be available soon.
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