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Read our independent data-driven reporting, analysis and commentary on the psychedelics space: from business and drug development through to policy reform and culture.

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The latest

Pα+ Psychedelic Bulletin #172: Lykos Scales Back IIT Program, CEO Steps Down; Psyence Scoops Up Clairvoyant for Peanuts; Mindstate’s Moxy Enters Phase I

September 9, 2024

Lykos Scales Back Investigator-Initiated Trials Program, Refers Some Researchers to PharmAla • Lykos Appoints ‘Pharma Veterans’ to C-Suite • Psyence Scoops Up Clairvoyant for Peanuts • Mindstate’s Moxy Enters Phase I Trial • Embattled Braxia Bought for $180k • UK Gov. Unveils £400m Plan to Catalyse Clinical Trials • GH Research Waiting on Tox Studies to Respond to FDA’s Clinical Hold • Cydex Sues Bexson Over Psychedelic Salt Patents • and more…

Exclusive: David Hough on Lykos’ Path to Resubmission

September 4, 2024

Josh sits down with the man drafted in by Lykos to plot a path to resubmitting its MDMA application. They talk about Hough’s experience in developing Spravato to eventual approval and how that might inform any future clinical development of MDMA, Hough’s thoughts about the FDA’s verdict and the AdComm that preceded it, what a future Phase 3 program might look like, and more…

What Does FDA Expect from Lykos’ Next Phase 3 MDMA Study? (Part 2)

August 28, 2024

In the second of a two-part series, we look at key trial design features FDA is expected to require of any future Phase 3 study from Lykos. Here, we run through how the MDMA drug developer will be expected to account for euphoria and other ‘positive’ adverse events, address selection bias, and favour larger academic and medical facilities as trial sites over private practices. What’s more, the company might be expected to outsource much of the trial’s day-to-day operations.

What Does FDA Expect from Lykos’ Next Phase 3 MDMA Study? (Part 1)

August 22, 2024

As the dust settles on FDA’s decision to not approve Lykos Therapeutics’ MDMA-assisted therapy for PTSD, we look at what the agency expects to see in the fresh Phase 3 study that it requested in its Complete Response Letter. In the first of a two-part series, we look at active placebos and evidence-based psychotherapies.

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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.

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Pα+ Library: Bifurcated Scheduling

December 6, 2023

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

November 15, 2023

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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Archived versions of our Psychedelic News Feed.