VA just gave MDMA to veterans. It's official.

VA Launches First MDMA Trial; Ibogaine Sourcing Named Next Bottleneck

  • The VA launched an RCT of MDMA-assisted therapy for PTSD and alcohol use disorder in ~80 veterans at VA Providence and VA Connecticut Healthcare Systems; participants receive MDMA-assisted therapy versus matched psychotherapy with active placebo (NCT07118839). The VA currently runs 19 active psychedelic trials backed by $23M+ in external funding.

  • VA Secretary Doug Collins told the Senate Veterans' Affairs Committee that ibogaine is the VA's next psychedelic priority, but no federal source for the compound is yet established and FDA clearance must precede procurement; the MDMA trial is described as ahead of schedule.

  • Collins also flagged workforce scalability as a constraint: MDMA treatment requires ~120 hours per patient with two psychiatrists simultaneously — a structural challenge for VA-scale deployment, per the same Senate testimony.


Legislation: PATH Caucus Moves to Codify EO; Oklahoma Signed; Michigan Scales Up

  • Reps. Correa (D-CA) and Bergman (R-MI), co-chairs of the PATH Caucus, are drafting legislation to permanently enshrine EO 14237 into statute — insulating psychedelic research funding from future administrations — with $30M annually for VA Centers of Excellence in psychedelic therapy included. RFK Jr. has pledged legal psychedelic access for military veterans within 12 months.

  • Oklahoma Gov. Kevin Stitt signed HB 3834 (Breakthrough Therapy Act), authorizing the state Dept. of Health to contract with developers for ibogaine trials targeting SUDs, PTSD, and TBI. No funding was appropriated; developers must provide cost-matching and FDA approval plans. Oklahoma joins Texas, Tennessee, and Louisiana among Republican-led states with enacted ibogaine research legislation.

  • Michigan lawmakers introduced bipartisan legislation to invest $50M in FDA-supervised ibogaine research for PTSD and opioid addiction — a substantially larger commitment than Rep. Greene's initial bill (previously reported May 21). NIDA Director Nora Volkow was cited concurrently as expressing increased enthusiasm for ibogaine based on emerging evidence.


TSND-201 Data Transparency Demanded; Right to Try Collision Surfaces

  • Researchers formally requested additional transparency from Transcend Therapeutics on its methylone (TSND-201) Phase 2 PTSD study — specifically: psychological support protocols provided to participants, whether participant guessing of treatment condition correlated with outcomes, and a more detailed mechanism of action. Transcend holds a CNPV despite methylone being the least Phase-mature of the three CNPV recipients (reported April 30).

  • A legal analysis identified a novel compliance collision under the Right to Try pathway: noribogaine's active IND could impose adverse-event reporting obligations on the drug sponsor for patients they do not directly control — an issue with no existing regulatory precedent, distinct from standard IND or compassionate use frameworks.

  • The American Psychiatric Association welcomed federal research investment in psychedelic therapies but expressed concern about expedited approvals; psychiatrists speaking to WBIR noted that FDA efficacy trials enroll highly selected populations and real-world effectiveness data in comorbid populations remains entirely unknown.


Norway and France Establish Generic Ketamine Reimbursement — A Potential Blueprint

  • A Drug Science analysis details Norway's August 2025 national reimbursement decision for off-label racemic ketamine in treatment-resistant depression — the first public funding of generic ketamine globally — built on open-source protocols, a national network (NORAAD), and a health technology assessment showing it is more cost-effective than ECT.

  • France became the second country in March 2026, reimbursing generic IV ketamine for suicidal crises under compassionate use (France's ANSM authorization previously reported April 16). Both nations chose generic racemic ketamine over patented esketamine, offering a potential public-health financing model for psychedelic reimbursement post-approval that bypasses branded drug pricing.


Pipeline: Cybin Phase 3 Initiated; Luvicylin Earns Postpartum BTD; COMPASS at ASCP

  • Cybin initiated the multinational Phase 3 PARADIGM program for CYB003, a deuterated psilocybin analog, in major depressive disorder — targeting 200+ patients across multiple countries, making it the fourth psilocybin compound in Phase 3 alongside COMP360, Usona's psilocybin, and Filament's PEX010.

  • Reunion Neuroscience's luvicylin, a subcutaneous psilocin prodrug, received FDA Breakthrough Therapy Designation for postpartum depression; the acute experience runs ~3–4 hours shorter than oral psilocybin — reducing per-session clinic time — and was first flagged at the ASCP annual meeting last week (previously reported May 21 as pipeline data behind a paywall).

  • COMPASS Pathways presented late-breaking Phase 3 poster data at the 2026 ASCP Annual Meeting (full content gated) and elected Kathleen Tregoning — a biopharma commercialization executive — to its board, with rolling NDA submission and CNPV review underway.

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