Special Dispatch: FDA Rejects Lykos’ MDMA Assisted Therapy Application

Welcome to a special episode of The Trip Report Podcast, a production of Beckley Waves, a Psychedelic Venture Studio.

Today, we’re dissecting the FDA’s rejection of Lykos Therapeutics MDMA Assisted Therapy with Dr. Carlene MacMillan MD, a Harvard-trained psychiatrist and Chief Medical Officer at Osmind.

In her role at Osmind, Dr. MacMillan has the unique experience of helping practices across the country adopt new treatment modalities like Ketamine, Spravato, and Transcranial Magnetic Stimulation.

And through her work with professional societies like the American Psychiatric Association and the Clinical TMS Society, she has been involved in developing policies, treatment codes, and access to new interventional psychiatric treatments. 

This background and experience made her a great person to speak with about the FDA decision, the most pivotal development this nascent field has seen.

In this special dispatch, we dive deep into the potential rationale and aftermath of the FDA’s decision, as well as the implications for the future of psychedelic therapies, research, and commercialization. 

In this conversation, we discuss:

* The allegations of research misconduct

* The difficulty the FDA and Advisory Committee had with the therapeutic component of the trial

* The complexities of psychiatric trial designs and the importance of reliable data.

* The role of real-world evidence and post-marketing data in evaluating new treatments.

* The challenges of integrating new therapies into mainstream healthcare.

* The future of psychiatric treatments, including neuromodulation and other emerging therapies.

* And much more.

And now, I bring you my conversation with Dr. Carlene MacMillan.

Listen to the episode on Substack, Spotify, Google or Apple.

Credits:

* Hosted by Zach Haigney 

* Produced by Zach Haigney, Erin Greenhouse, and Katelin Jabbari

* Find us at thetripreport.com

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* Theme music by MANCHO Sounds, Mixed and Mastered by Rollin Weary