Trip Report Special Dispatch

FDA grants Usona Breakthrough Therapy Designation for Major Depressive Disorder

Hello Trip Report Readers,

Please accept my apologies for going off our Wednesday/Sunday cycle but this is a special dispatch that we thought you might want to see.

Yesterday the Usona Institute, the Wisconsin based non-profit pharmaceutical organization, announced that they have received Breakthrough Therapy Status for Psilocybin in the Treatment of Major Depressive Disorder from the FDA

Usona Institute @usonainstitute

Exciting announcement! Usona's psilocybin program for major depression has received Breakthrough Therapy Designation from the FDA. Read more:

businesswire.comFDA grants Breakthrough Therapy Designation to Usona Institute’s psilocybin program for major depressive disorderUsona Institute’s psilocybin program for major depressive disorder has received Breakthrough Therapy Designation from the US FDA.

BTS from the FDA is a BFD

I’ll have more to say about this particular decision for this particular diagnosis and this particular organization in Wednesday’s Weekly Report but suffice it to say, this is fucking epic. It is well deserved and an important step in getting closer to a more effective and humane approach to mental and emotional health.

And Usona Medical Director Charles Raison agrees (and throws some shade):

“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials. What is truly groundbreaking is FDA’s rightful acknowledgment that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,”

If you understand the significance of the emphasized portion then perhaps you’ll enjoy the meme below

The Trip Report Newsletter @TheTripReport1

"What is truly groundbreaking is FDA’s rightful acknowledgment that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement"