Exciting progress is happening in the psychedelic industry every day. We’ve rounded up some of the major highlights from the past few weeks so you can stay up-to-date on the biggest news and the latest updates in the field. Let’s dive in.
- Last month, the MAPS Public Benefit Corporation (now called Lykos Therapeutics) officially submitted a New Drug Application (NDA) for their investigational MDMA-assisted therapy for PTSD. This submission marks the culmination of over 30 years of research and is the first NDA filed for a psychedelic-assisted therapy in the US. Approval of this application by the FDA would make their MDMA-assisted therapy protocol (which includes psychotherapy and support from a qualified healthcare provider) available for prescription medical use in the US for individuals with moderate to severe PTSD, a major milestone.
- As of January 1st, three new CPT III codes for psychedelic therapy officially came into effect. CPT codes offer a standardized language for medical professionals to report the medical services they provide. CPT III codes are a special category designated for new services and procedures. The new codes describe in-person monitoring and intervention during psychedelic therapy. These codes allow for the collection of real-world data from clinical practice and are integral for ensuring future accessibility and insurance reimbursement.
- Compass Pathways and Greenbrook TMS have announced they’re teaming up for a three-year collaboration to research the most effective ways to deliver Compass’s investigational COMP360 psilocybin treatment to patients upon FDA approval. The collaboration will explore how to provide the best patient care experience, how to best support therapists and healthcare providers, and the use of supporting tools and modalities to develop a scalable model for implementing this treatment into the healthcare system.
- Earlier this month, researchers at Stanford published their findings from a research study looking at the effects of the psychedelic drug ibogaine in a population of Veterans with traumatic brain injury (TBI). TBIs are a leading cause of PTSD, depression, and anxiety, and a reliable, effective treatment has not yet been established. The study found that treatment with ibogaine was associated with a dramatic reduction in symptoms of PTSD, depression, and anxiety, as well as an improvement in overall brain functioning. Read the full paper in Nature.
- Another recently published study explored the effects of MDMA-assisted therapy on "self-experience" in patients with PTSD. Self-experience is a term that refers to mental processes related to one's sense of self, such as self-identity, self-compassion, self-awareness, and the ability to identify, describe, and express emotions. The study found the treatment was associated with significant positive improvements across various domains of self-experience, implying a potential underlying factor contributing to the therapeutic benefits of MDMA-assisted therapy for individuals with PTSD. Read the full paper in PLOS ONE.
- Scientists are using a powerful AI tool called AlphaFold to discover potential new psychedelic molecules, which could lead to the development of novel antidepressant drugs. AlphaFold, developed by DeepMind, can predict the structure of nearly every known protein, making it a valuable tool for drug discovery and design. Read more about AlphaFold in this Scientific American article.
Law & Policy
Across several states, there is growing support for psychedelic policy reform:
- In Massachusetts, activists successfully gathered over 96,000 signatures for a psychedelic legalization initiative, surpassing the threshold required to force state legislators to consider the psychedelic legalization measure.
- New Hampshire's House Bill 1693 aims to legalize medical psychedelics, potentially challenging federal prohibition.
- California is actively working on several initiatives to legalize or decriminalize psychedelics, focusing on medical therapeutic access.
- Washington State is considering legislation to allow nonprofits to offer psilocybin services to Veterans and first responders.
- Connecticut lawmakers are considering reintroducing a bill to decriminalize psilocybin in 2024 after a similar bill made progress but stalled in the Senate last year.
- Last year, Colorado became the first state in the US to legalize the possession and use of psychedelics. Governor Jared Polis celebrated this milestone in his recent State of the State address, recognizing Colorado as “leading the nation” in psychedelic policy reform.
If you’re interested in getting a more comprehensive overview of the state of psychedelic legislation initiatives throughout the United States, check out Psychedelic Alpha’s Psychedelic Legalization & Decriminalization Tracker.
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