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Writer's pictureAshley Hornbuckle

A new study shows how psilocybin-assisted therapy could affect more than 5 million people in the US pending approval from the FDA.



Millions of Americans struggling with major depressive disorder (MDD) and treatment-resistant depression (TRD) face daunting treatment options like electroconvulsive therapy, ketamine infusions, or long-term antidepressants. But a new study suggests psilocybin-assisted therapy (PSIL-AT), pending FDA approval, could provide transformative relief for over 5 million people.


Who Could Benefit?

Researchers analyzed national data on individuals receiving treatment for MDD and TRD, excluding those with conditions like heart failure or diabetes that might make psilocybin therapy unsafe. The study found that 56-62% of patients—about 5.1 to 5.6 million people—could be eligible for PSIL-AT, highlighting the vast need for effective new treatments.

“This research goes beyond clinical trials to explore the broader public health and economic impacts of making psilocybin therapy widely available,” says Fayzan Rab, lead author and MD candidate at Emory University.


Where Is Psilocybin Therapy Now?

Psilocybin-assisted treatment is currently under the FDA’s breakthrough designation, which fast-tracks review of therapies with transformative potential. Rab notes that the study provides crucial data to guide the FDA's review process: “This is how many Americans we think are at stake.”


Should the therapy gain approval, public and private insurers will play a pivotal role in determining access. With 20% of Medicaid beneficiaries—around 17 million people—likely affected by depression, decisions on reimbursement for PSIL-AT could shape its reach and impact.


Speedy Relief and Economic Benefits

Psilocybin therapy has shown promise in reducing symptoms of depression after just a single 25 mg dose, potentially offering faster and longer-lasting relief compared to traditional antidepressants. George Grant, co-director of Emory’s Center for Psychedelics and Spirituality, emphasizes the significance: “Fast-acting interventions like psilocybin could reduce the financial burden on healthcare systems while transforming lives.”

Grant adds that beyond economic savings, psilocybin’s therapeutic potential may help people find deeper purpose and satisfaction in life, offering not just symptom relief but meaningful healing.


A Promising Future

This study provides policymakers and health agencies with a compelling vision of how PSIL-AT could reshape mental health care. With continued research and thoughtful implementation, psilocybin therapy could offer hope to millions in need.


Sources:

  • Emory University News

  • Original Study: DOI: 10.61373/pp024r.0025

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