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Vincent Joralemon preprint
Psychedelic therapies—ketamine, MDMA, psilocybin, LSD, DMT, and ibogaine—are moving from prohibition to regulated care, but commercialization hinges on FDA approval, DEA scheduling, and payor (insurance) coverage. This Article maps the U.S. regulatory labyrinth and analyzes how business models succeed or fail under these constraints. It explains bifurcated rescheduling (DEA reschedules the...
Vincent Joralemon preprint
As psychedelic-assisted therapies advance through the FDA approval pipeline, the question of who will pay for them is moving from academic to urgent. Experts project that MDMA-assisted therapy for PTSD will cost upwards of $11,000-$12,000 per course of treatment-a price tag that, absent insurance, places these therapies out of reach for many of the patients most likely to benefit. This essay...
Nestor Girala
Introduction There is a growing and renewed interest in the use of hallucinogenic drugs in the treatment of psychiatric disorders, especially since the FDA approval of esketamine treatment for resistant depression. The response to hallucinogenic psychedelic substances (ayahuasca, psilocybin, LSD, ketamine) in the treatment of depression and addictions calls for a theoretical explanatory model....
Viviana D. Evans, Alejandro Arenas, Kenneth Shinozuka et al. preprint
Background: Ketamine, an arylcyclohexylamine dissociative anesthetic agent, has evolved into a versatile therapeutic. It has a rapid onset, well-understood cardiovascular effects, and a favorable safety profile in clinical use. Its enantiomeric compound, esketamine, was approved by the FDA in 2019 for both treatment-resistant depression as well as major depressive disorder (MDD) with suicidal...
Michael Alvear preprint
This report summarizes more than 25 systematic reviews and meta-analyses published between 2020 and 2025 on ketamine-based therapies for depression. It provides a comparative analysis of intravenous (IV) ketamine, esketamine nasal spray (Spravato), and oral ketamine, highlighting differences in response rates, remission rates, speed of symptom relief, and durability of results.It also examines...