In this episode, Joe interviews Dr. Amanda Holley: pharmacologist and regulatory consultant in nonclinical drug development, and previously a nonclinical pharmacology/toxicology reviewer at the FDA.

With Lykos Therapeutics working towards FDA approval of MDMA-assisted psychotherapy for PTSD, ICER (Institute for Clinical and Economic Review) recently published its draft evidence report, concluding that they couldn’t endorse this modality. While disappointing to the psychedelic space, this report doesn’t determine the FDA’s official stance, and also really highlights a lot about how the FDA works, the knowledge gap between consumers and regulators, and how clinical studies should be designed in the future. Holley talks about the FDA’s dedication to safety and data, and how, essentially, drug development comes down to a risk/benefit analysis. 

She discusses:

• Misconceptions about the FDA, especially related to psychedelics
• The path of a substance in early drug development and how breakthrough designation works
• The complications with blinding psychedelics, the placebo effect, and how much therapy is a factor
• The contrast between productization and harm reduction: Should we be concerned with creating products, or understanding these substances better?
• How changing one molecule really does create a different drug

and more!

Links

Icer.org: Institute for Clinical and Economic Review Releases Draft Evidence Report on Treatment for Post-Traumatic Stress Disorder

3,4-Methylenedioxymethamphetamine Assisted Psychotherapy for Post-Traumatic Stress Disorder (PTSD): Draft Evidence Report

Psychedelicalpha.com: Exclusive: Therapists and Trialists from Lykos’ Phase 3 MDMA-Assisted Therapy Studies Push Back on ICER’s Critical Draft Report

Lykospbc.com: Lykos Therapeutics Statement on FDA Advisory Committee Meeting

Marijuanaindex.com: Delta 8 vs Delta 9 THC: Understanding the Differences and Effects

David Nutt’s drug harm scale