Insights

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

Natural Medicine Advisory Bulletin 9: Feb/Mar 2024

Vicente LLP shares its summary of the NMAB meeting and Department of Revenue Listening Session in February 2024, as well as a Listening Session and Department of Regulatory Agencies Stakeholder Engagement Meeting in early March 2024.

Gilgamesh Scoops $14m from NIDA to Develop Safer Ibogaine Analog for Opioid Use Disorder

Psychedelic drug developer Gilgamesh Pharmaceuticals has scooped a grant worth $14m from the National Institute on Drug Abuse (NIDA) to develop its ibogaine analog, GM-3009, for opioid use disorder (OUD). The company hopes that the compound will prove to be ‘cardiac-safe’, alluding to concerns around ibogaine’s cardiotoxicity which may represent a barrier to achieving FDA approval for the drug.

FDA Hands MindMed’s LSD Candidate Breakthrough Therapy Designation in Generalised Anxiety Disorder; Company Provides 12-Week Data and Fleshes Out Phase 3 Program Plans

Psychedelic drug developer MindMed announced today that the FDA has granted breakthrough therapy designation to its LSD-D-tartrate candidate (MM120) for the treatment of generalised anxiety disorder (GAD). The company also shared topline 12-week data from the same program, as well as results of a pharmacokinetic bridging study and further details on phase 3 study design.

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.

The Psychedelic News Feed Archives

Archived versions of our Psychedelic News Feed.