This Week in Psychedelics

Exciting updates on MDMA therapy for veterans and new PTSD treatments

April 26, 2024

This Week...

Bipartisan congressional lawmakers asked the U.S. Department of Veterans Affairs (VA) to produce a plan to begin providing MDMA-assisted therapy for veterans as soon as the psychedelic is approved by the Food and Drug Administration (FDA).

In a letter sent to VA Under Secretary Shereef Elnahal on Tuesday, Reps. Morgan McGarvey, Morgan Luttrell, and seven other members said the FDA could approve alternative treatments for post-traumatic stress disorder (PTSD) such as MDMA “as soon as this summer,” demanding planning on VA’s part. Here’s more: https://www.marijuanamoment.net/bipartisan-congressional-lawmakers-tell-va-to-prepare-plan-for-mdma-assisted-therapy-as-fda-considers-approving-the-psychedelic/

Silo Pharma announced positive data in the final validation report from the recent pharmacokinetic (PK) study of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress disorder (PTSD). The PK study was conducted as part of non-GLP small animal dose-ranging study of SPC-15 completed in February 2024.

The activity of SPC-15 in the subjects or the PK study was evaluated over a 7-day repeat intranasal dose, including the processes of absorption, distribution, and excretion. Time to peak drug concentration occurred between 0.5 and 2 hours following intranasal administration compared to 2 hours following oral gavage administration. In previous findings from the non-GLP study, SPC-15 demonstrated rapid absorption with good exposure over a full 24-hour period, and based on these studies we determined an optimal once-per-day human intranasal dosing. Check it out: https://www.biospace.com/article/releases/silo-pharma-announces-positive-results-for-intranasal-ptsd-treatment/

atai Life Sciences announced that the first patient has been dosed in Part 2 of Beckley Psytech’s Phase 2a study, evaluating BPL-003 (intranasal 5-MeO-DMT) in patients living with Treatment Resistant Depression (TRD).

In Part 2 of this open-label Phase 2a study, patients with moderate-to-severe TRD who are on a stable course of certain oral selective serotonin reuptake inhibitor (SSRI) antidepressants will receive a single dose of BPL-003 alongside psychological support to explore the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of BPL-003 as an adjunctive therapy to SSRIs. Patients will be followed for 12 weeks post-dosing. Initial results are expected in H1 2025.  Here’s more: https://finance.yahoo.com/news/atai-life-sciences-announces-dosing-110000787.html

Did You Know?

Did you know dinosaurs may have eaten “ancient LSD?”

About ten years ago, researchers discovered the world's oldest piece of grass, perfectly preserved inside a piece of amber unearthed in Myanmar. Also encapsulated in the amber fossil was an ancient fungus similar to ergot, a fungus involved in the original synthesis of LSD.

The discovery suggests this psychotropic fungus has evolved alongside the grasses and cereal grains that came to make up much of the modern diet. But long before humans ever ate grasses (and the fungi that grow on them), it is likely massive dinosaurs consumed the hallucinogen. Here’s more: https://www.upi.com/Science_News/2015/02/11/Amber-fossil-suggests-dinosaurs-may-have-eaten-ancient-LSD/4041423671087/