A Mental Health Crisis Decades in the Making
A Mental Health Emergency Requiring New Tools.
More than 50 million patients in the United States are diagnosed with significant mental health conditions including post-traumatic stress disorder (PTSD), treatment-resistant depression (TRD), generalized anxiety disorder (GAD), major depressive disorder (MDD), and substance use disorder (SUD). Yet, new treatments and therapies have not kept pace with the growing crisis.
We must explore and advance novel treatments to help patients struggling with PTSD, TRD, GAD, MDD, SUD, and other mental health conditions.
The Innovation Gap
The current standard of care has failed to advance in decades. There has been no significant PTSD innovation since the early 1990s, and 70% of people with depression do not achieve full remission with first-line SSRI or SNRI treatments.
The Suicide Epidemic
Every 11 minutes, a fellow American dies by suicide—resulting in 50,000 lost lives per year. This crisis is particularly acute for our veterans, with 17 to 44 veterans dying by suicide every single day.
The Economic Burden
Beyond the human cost, mental illness costs the United States $282 billion each year in lost productivity and care.
1 in 5 adults experience symptoms of anxiety and depression
Broad and safe access to these innovative treatments can only be achieved if they are FDA-approved and reimbursed through a patient’s health insurance carrier.
The Medical Model: Safety, Certainty, and Access.
Advanced clinical trials involving psychedelics continue to demonstrate promising results, with research showing that a single dose of psilocybin can produce rapid and persistent therapeutic effects.
As the leading voice for prescription psychedelic medicine, we believe the FDA New Drug Application (NDA) approval pathway is the only appropriate mechanism to ensure American patients can safely and effectively access these treatments.
FDA Approval is the Only Way
FDA approval ensures that medicines meet rigorous standards for safety and efficacy. This pathway is essential for securing insurance reimbursement, establishing Risk Evaluation and Mitigation Strategies (REMS), and ensuring standardized dosing for every patient.
Defined Protocols
Unlike state legalization models, the medical model ensures these therapies are administered by licensed professionals in controlled, clinical settings. Rigorous screening protocols will allow physicians to identify and protect individuals who should not receive the therapy.
The Pipeline
The FDA has recognized the potential of these therapies by granting Breakthrough Therapy Designations (BTD) to several compounds. Current research highlights include:
• MDMA (PTSD): 67% of patients no longer met diagnostic criteria after three sessions.
• Psilocybin (MDD/TRD): 83% of clinical trial participants saw significant reductions in depressive symptoms.
• LSD (GAD): Emerging research suggests potential as a therapeutic agent for psychiatric disorders.
• Deuterated Psilocin (MDD): 100% of 16 mg patients receiving 2 doses were responders at 12 months
Ending the Decades-Long Stagnation in Mental Healthcare
Join a coalition of industry leaders and policy experts dedicated to delivering safe, FDA-approved, and life-saving prescription psychedelic medicines to the millions of Americans who have run out of options.