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FDA-Approved Ibogaine Therapy for Addiction

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Sheldon Pelletier
Sheldon Pelletier
Health & MedicineTechnology
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A Non-Profit Approach to Developing Ibogaine into an FDA-Approved Medication Rick Doblin, PhD Multidisciplinary Association for Psychedelic Studies
Three Basic Points ,[object Object],[object Object],[object Object]
FDA’s Track Record ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
FDA is our Ally ,[object Object],[object Object],[object Object]
FDA Organizational Change ,[object Object],[object Object]
FDA Institutional Change ,[object Object],[object Object],[object Object]
FDA’s New Policy for Psychedelic Research ,[object Object],[object Object]
FDA Follows Through: MDMA ,[object Object],[object Object]
FDA Follows Through: Ibogaine ,[object Object],[object Object]
NIDA: Just Say Maybe, Not. ,[object Object],[object Object]
FDA Input to NIDA ,[object Object],[object Object]
Dr. Wright’s Letter to NIDA ,[object Object]
Dr. Wright’s Letter to NIDA ,[object Object]
NIDA: Just say No! ,[object Object]
Ibogaine Research: Not Enough $$$ ,[object Object],[object Object],[object Object]
NIDA in 2003 ,[object Object],[object Object]
Privately-Funded Ibogaine Research ,[object Object]
The Costs of Drug Development: A Stretch but Within Reach ,[object Object],[object Object],[object Object]
Drug Development $ Estimates ,[object Object],[object Object]
Major Papers ,[object Object],[object Object],[object Object]
Most Recent Estimate ,[object Object],[object Object]
Industry Insider View ,[object Object]
Whittling Away ,[object Object],[object Object],[object Object],[object Object]
Opportunity Cost ,[object Object],[object Object]
Cost of Failures ,[object Object]
Number of Failures Per FDA-Approved Drug ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Cost of the Failures ,[object Object],[object Object]
Preclinical v. Clinical Costs ,[object Object]
Cost of Success ,[object Object],[object Object],[object Object]
Small firm/Non-Profit Advantage ,[object Object],[object Object]
Still Big Numbers, But... ,[object Object],[object Object]
The Advantage (Finally) of working with Demonized Drugs ,[object Object],[object Object]
Medline Papers on Ibogaine ,[object Object],[object Object]
Quasi-Underground Research ,[object Object],[object Object]
Estimating Number of Subjects: Pilot Studies ,[object Object],[object Object]
Patients to be Enrolled in Phase III Clinical Trials ,[object Object],[object Object]
Patients Enrolled in All Studies ,[object Object],[object Object]
Cost per Patient in US Clinical Trials ,[object Object],[object Object]
Summary Estimates ,[object Object],[object Object],[object Object]
Relative Costs ,[object Object],[object Object],[object Object]
Step 1: Comprehensive Literature Review ,[object Object],[object Object]
Step 2: Obtain Independent Supply ,[object Object],[object Object]
Step 3: Complete Phase 1 Study. ,[object Object],[object Object]
Step 4: Standardize ,[object Object],[object Object]
Step 5: Conduct Phase 3 Studies ,[object Object],[object Object]
Non-Profit v. For-Profit ,[object Object],[object Object]
Final Thought From Albert Einstein ,[object Object],[object Object]
If Psychedelics Become Prescription Medicines, How Should They be Regulated? ,[object Object],[object Object]
DEA Fear: Legalization for Medical Use = Legalization for All uses. ,[object Object],[object Object]
The Issue of Off-Label Prescriptions ,[object Object],[object Object],[object Object]
DEA Relatively Weak After Drug Approved for Marketing ,[object Object],[object Object]
Key FDA Regulatory Issues ,[object Object],[object Object]
Strategic Approach: Incremental Change ,[object Object],[object Object]
Limits Imposed by Regulatory System ,[object Object],[object Object],[object Object],[object Object]
Limits Can Be Relaxed Over Time ,[object Object],[object Object]
Contingency Plan in Case of Success ,[object Object]
Putting on My Authoritarian Hat ,[object Object],[object Object]
Rules for Radicals ,[object Object],[object Object]
Are you experienced? ,[object Object],[object Object]
Are you experienced? ,[object Object],[object Object]
The Psychedelic Clinic ,[object Object],[object Object],[object Object]
Staffing Requirements ,[object Object],[object Object]
Staffing Requirements ,[object Object]
National Patient Registry ,[object Object],[object Object]
Mail - Order Prescriptions Only ,[object Object],[object Object]
Advertising ,[object Object],[object Object]
Gradual Expansion of the Function of the Clinic ,[object Object],[object Object],[object Object],[object Object],[object Object]

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FDA-Approved Ibogaine Therapy for Addiction

  • 1. A Non-Profit Approach to Developing Ibogaine into an FDA-Approved Medication Rick Doblin, PhD Multidisciplinary Association for Psychedelic Studies
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