Health MDMA for PTSD granted Expanded Access by FDA, patient treatments begin

tom_mai78101

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Marking an impressive milestone in the development of MDMA-assisted psychotherapy for PTSD, the U.S. Food and Drug Administration (FDA) has approved the treatment for Expanded Access, allowing certain patients access to the therapy before full market approval is granted. Ten treatment clinics in the United States are reported as ready to commence administration of the therapy, while Phase 3 trials are ongoing and full approval is estimated for 2022.

It takes a long time for a new pharmaceutical treatment to move from initial discovery to market approval. The process of human clinical trials alone can take anywhere from five to seven years, and that is assuming everything goes perfectly. The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) has been working for decades to establish MDMA-assisted psychotherapy for PTSD.

The FDA’s Expanded Access program is designed to allow patients with serious illnesses access to treatments still in the processes of clinical investigation. Often informally referred to as the compassionate use program, Expanded Access offers individuals conditional access to specific treatments.

MDMA-assisted psychotherapy for PTSD is currently deep in Phase 3 clinical trials. While complete market approval is still most likely two to three years away, Expanded Access to the treatment has now been granted by the FDA.


Read more here. (New Atlas)
 
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    i may have some time, pretty sure I brought covid home from vegas, got tested today, will know for sure tomorrow or next day
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    meh, me, wife and her friend thaty traveled with us all have covid, seems to be winding down some for me at least. Felt like complete shit, been sleeping a lot, just bieng lazy as hell. I feel like that today has probably been like 11 or 12 days since exposure. Have not had any fever today, and have not taken any meds, so hopefully by monday or tuesday I will be good to go, sadly have passed it on to our teen son, I guess that was pretty much unavoidable
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    I will at some point, but so many vaccinated people still getting it. One of the bands we watch in vegas, all 4 had been vaccinated and are now positive.
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    we wore mask in some places, but at 118 degrees outside, little rough. :)
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