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The latest

Developing Esketamine (Spravato) and Lessons for Psychedelic Drug Developers with Jaskaran Singh

Josh Hardman sits down with Jaskaran (‘Jaz’) Singh, who spearheaded the development of esketamine for treatment-resistant depression, now marketed as Spravato. We discuss how Singh’s early work assessing ketamine’s antidepressant effects at the National Institute of Mental Health (NIMH) encouraged him to move into industry; how his team decided to pursue esketamine; lessons learned that might be relevant for psychedelic drug developers; and his broader outlook on the field.

MindMed’s ‘Total Elimination’ of Psychotherapy in LSD Study Stokes Debate Around Its Role in Psychedelic Therapies

In March, MindMed scored an FDA Breakthrough Therapy Designation for its LSD-D-tartrate candidate (MM120) for generalised anxiety disorder (GAD). Here, Josh takes a closer look at the company’s claim to have ‘eliminated’ psychotherapy from its Phase 2b study of MM120 and explores how a ‘Spravato-isation’ of psychedelic therapies is stoking broader debates around the contribution of psychotherapy in psychedelic therapies or ‘treatments’.

Senator Kirk Cullimore on Utah’s MDMA and Psilocybin Pilot Program

Josh Hardman speaks with the chief sponsor of Utah SB 266, which became law last month. The bill sees the creation of a pilot program that allows MDMA and psilocybin therapies to be administered at two health systems in the Beehive State. Questions remain, however, around the likelihood of these health systems engaging in such activity, as well as potential repercussions from federal agencies and professional bodies alike.

Pα+ Psychedelic Patent Analysis: February 2024

This month: We Explore IP and Exclusivity in MDMA Drug Development Across Lykos, atai, MindMed, Arcadia, and PharmAla • Browse the Interactive Psychedelics Patent Database for February 2024

The Library

Through our years of reporting we have covered many of the topics we believe to be important to the present and future of the psychedelics space, broadly defined. However, much of this commentary is scattered across Bulletins, deep dives, special reports and year-end reviews.

The Library provides digestible explainers on salient topics across psychedelic drug development, policy and business: from basic explainers such as “what is psychedelic-assisted therapy?” through to more complex matters such as REMS programs and bifurcated scheduling.

It’s exclusively available to our Pα+ subscribers, with new content added regularly.

Pα+ Library: Bifurcated Scheduling

Pα+ Library: we introduce some of the key concepts in the matter of bifurcated scheduling; a process by which an approved drug product may be placed in a different schedule to the substance itself. As we discuss in this piece, this could have significant repercussions for psychedelic research, legality, and even taxes.

Pα+ Library: Psychedelic REMS

Pα+ Library: we sketch out what a psychedelic REMS might look like, highlighting how these programs could have an outsized impact on the post-approval delivery and accessibility of these treatments.

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