Psychedelic Medicine: Updates from the field with Lynn Marie Morski, JD, MD

In this episode, Psychedelic Medicine Podcast host, Dr. Lynn Marie Morski, provides the latest updates from the field of psychedelic medicine. Dr. Morski discusses the breakthrough therapy designation which a number of psychedelic compounds have received in the past few years, the most recent of which is BPL-003, a nasal spray formulation of 5-MeO-DMT. One of the exciting aspects of this new compound, Dr. Morski notes, is that it is shorter-acting than most serotonergic psychedelics—a feature which may make treatment with this substance less expensive and more accessible.

Another exciting development is the COMPASS Pathways phase 3 trial of COMP360 psilocybin. Dr. Morski shares that the company believes they are nine to twelve months ahead of schedule, which means that if all goes well, this psilocybin compound could be approved for treatment resistant depression as early as sometime in 2027. She also discusses why the US FDA said they rejected MDMA for PTSD and what this governing body would like to see from subsequent research before reconsidering this decision. In closing, Dr. Morski shares excitement about the development of novel psychoplastogens—the non-hallucinogenic psychedelics—which may help bring many of the same healing benefits to populations currently unable to be served by the existing compounds under investigation.

In this episode, you'll hear:

• Which psychedelics currently have breakthrough therapy designation and for which indications
• Details of recent ketamine research for inpatient depression care and why these results are not as negative as they may seem
• The current horizons of psychedelic research and what indications may soon be explored
• Sources of hope in the current state of psychedelic research and the legal landscape

Quotes:

"[BPL-003] showed rapid and durable antidepressant outcomes after a single dose. … here we have something that is under an hour [of psychedelic experience] for treatment resistant depression." [7:43]

"Keeping patients blinded to whether or not they got the placebo or MDMA is a big focus that [the FDA] wanted to emphasize for these future phase 3 trials." [19:07]

"I know we had a big setback last year. I think a lot of us thought by this time we'd be a year into MDMA being approved and we're not. However, there are so many things on the horizon that are worth being excited about." [23:48]

Links:

Psychedelic Medicine Podcast on Instagram

Psychedelic Medicine Podcast on YouTube

Jelovac A, McCaffrey C, Terao M, et al. "Serial Ketamine Infusions as Adjunctive Therapy to Inpatient Care for Depression: The KARMA-Dep 2 Randomized Clinical Trial" JAMA Psychiatry, 2025.

Beckley Psytech Limited Phase 2 Trial: BPL-003 Efficacy and Safety in Treatment Resistant Depression

COMPASS Pathways Phase 3 Trial: Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD

Food and Drug Administration (FDA) Complete Response Letter (CRL) to Lykos Therapeutics, declining to approve MDMA-assisted therapy for Posttraumatic Stress Disorder

Psychedelic Alpha Psychedelic Drug Development Bullseye Chart

Psychedelic Medicine Association

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