Optimi is a commercial-stage pharmaceutical company manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies. $OPTH
Canada
Joined April 2021
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Researchers are optimistic about psychedelic drugs as potential treatments for depression and mood disorders, despite pushback having stalled the field
go.nature.com/4iH8B9o
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Two years ago the FDA rejected the first psychedelic therapy for PTSD. Today the US government is openly asking how it can get these treatments to millions of veterans as quickly as possible.
That is a remarkable shift, and in my view it is not mainly about politics. It is about the fact that conventional psychiatry has very little to offer people with severe PTSD or treatment-resistant depression. Many veterans did not wait for Washington. They travelled to Mexico, got treated and came back with stories that were impossible to ignore.
The brain is the last great frontier in medicine. Psychedelics are one of the first tools that actually change how it works, rather than just managing symptoms.
Article in the comments.
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Since President Trump's psychedelics-focused Executive Order in April, a slew of federal agencies and departments have engaged in related activities: from funding psychedelic research through to public hearings and requests for information.
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New episode: Peaking director Jordan Kronick on taking cameras into the dosing room across six psychedelics, the 2004 doc that helped reopen MDMA research, and psychedelics for brain injury in pro sports.
bit.ly/pt662-peaking
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Early Healthcare Forum Takeaways, FDA’s Ibogaine Blueprint, and Compass Talks Pricing
In this episode of The Psychedelic News Feed podcast, Psychedelic Alpha’s editor Josh Hardman runs through the last two weeks in the psychedelics field, including these stories:
• Early Notes from The Psychedelic Healthcare Forum
• FDA Floats an Ibogaine Trial Design, Asks Field for Input
• Compass Talks Pricing, Label and a Slow Launch
• New Mexico Nears Medical Psilocybin Launch
• Six More Potential Psychedelic Brand Names
Listen on our website or on your favourite podcast app: psychedelicalpha.com/news/po…
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As psychedelic treatments approach potential FDA approval, psychiatrists need to be ready for patients’ questions.
To help prepare them, Johns Hopkins, Yale, NYU, and Columbia developed a standardized psychedelic medicine curriculum for psychiatry trainees. The first multi-site evaluation of the course was just published in Academic Psychiatry.
After the course:
💡 Confidence counseling patients about clinical research and legal care nearly doubled
🔬 Understanding of the limitations of current evidence rose sharply
📈 Knowledge quiz scores improved
⚖️ Trainees gained a more balanced, critically informed view of the evidence, without inflated enthusiasm for the field
We’re continuing to develop educational and training programs for professionals across a range of fields, so stay tuned!
doi.org/10.1007/s40596-026-0…
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See our new paper on Psilocybin for Anhedonia in Unipolar and Bipolar Depression
sciencedirect.com/science/ar…
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Sounding the alarm - if MDMA & psilocybin are approved by FDA, most MDMA & psilocybin could still be scheduled I, wildly inconsistent with the science. @Ravarora1 & I lay out the case for why we need to avoid a "bifurcated schedule" that only reschedules the commercial FDA approved product. Please repost & spread the word! illusionconsensus.com/p/psyc…
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There hasn’t been anything new developed in the past 4 decades to treat mental health issues from anxiety to OCD to depression to bipolar disorder. Finally there is something new that is proven to help. Hope the USA takes the lead here and now and gets these drugs developed.
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As the Trump administration seeks to fast-track psychedelic drugs, the FDA could approve one for the first time early next year. But that possibility has brought up complicated questions about who should be allowed to administer the treatments and under what conditions. nbcnews.com/health/health-ne…
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Experts weigh in: If the FDA approves psychedelics, what comes next? fiercepharma.com/pharma/psyc…
Optimi retweeted
As the Trump administration seeks to fast-track psychedelic drugs, the FDA could approve one for the first time early next year. But that possibility has brought up complicated questions about who should be allowed to administer the treatments and under what conditions. nbcnews.com/health/health-ne…
Optimi retweeted
As the Trump administration seeks to fast-track psychedelic drugs, the FDA could approve one for the first time early next year. But that possibility has brought up complicated questions about who should be allowed to administer the treatments and under what conditions. nbcnews.com/health/health-ne…
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The U.S. Food and Drug Administration (FDA) has today shared how a potential domestic, early-phase clinical trial of ibogaine could shape up, via a 20-page document due to be published in the Federal Register tomorrow.
Through ARPA-H and NIDA, the Department of Health and Human Services expects to fund the first federally supported trials of the drug in opioid use disorder and PTSD. But FDA is charting a cautious path, flagging cardiac concerns in humans and neurotoxicity seen in animal studies.
Key features of FDA’s proposed trial design include:
Participants enrolled in “sequential dose ascending groups”, 10 mg/kg cap
Participants dosed one at a time, with potential dose increases from cohort to cohort considered “after appropriate review”
Dosing takes place in an inpatient unit equipped for cardiac emergencies, with continuous cardiac monitoring
Only fast and intermediate CYP2D6 metabolisers enrolled
Participants stop certain medications, like opioid agonists and SSRIs
Strict stopping rules and cognitive follow-up for 12 months
The agency is now seeking public comments on its thinking around ibogaine drug development via a 45-day Request for Information.
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Australia is now leading the world, and I couldn't be prouder of what we've built together. 💫
When Peter and I founded @MindMedicineAU, our dream was that no one should keep suffering when safe and effective treatments exist. Today, Australia is the first country in the world to recognise these medicines for clinical use, and more than 400 patients have been treated. When I hear that children "have their parents back," I know why we do this work.
Peter and I have written an article on how Australia got here and what's coming next. Read it here: buff.ly/QVZQo8U
💙 Help someone access life-changing treatment: buff.ly/a5Wqp6W
Please share, because everyone deserves the chance to heal.
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Portland, OR Council Makes Non-Commercial Use of Natural Psychedelics Lowest Law Enforcement Priority
Today, the City of Portland voted unanimously to amend its City Code to specify that personal, non-commercial use of "certain naturally occurring plant- and fungus-based psychedelic substances" be deemed as a "low law enforcement priority".
It does so by adding a chapter, Psychedelic Health and Safety, to that Code.
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@Optimi_Health just released a dope cGMP batch of naturally derived psilocybin capsules from its Canadian facility, supplying both a Phase 2 depression trial and commercial customers in Australia.
Fungi were once food, poison, medicine, myth.
Now they are becoming pharmaceutical supply chains.
The strange becomes ordinary the moment biology becomes reproducible.
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New research provides evidence that a single dose of psilocybin can durably increase social behavior in mice with genetic traits related to autism. The findings indicate that these behavioral benefits occur even if the mice are anesthetized during the… dlvr.it/TVdCYy
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We are thrilled to share a major milestone for the Johns Hopkins Center for Psychedelic and Consciousness Research: @CeydaSayali, PhD, has received an R01 award from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) — the first R01 awarded to an investigator at our Center.
The study will test a novel treatment approach for alcohol use disorder (AUD) combining psilocybin with personalized repetitive transcranial magnetic stimulation (rTMS). This is the first study to investigate this combination for AUD, with rTMS targets individualized using fMRI to identify each participant’s brain circuitry involved in regulating alcohol craving.
Using fMRI and TMS-EEG, the study will also examine how this combined intervention changes the neural mechanisms underlying craving, cognitive control, and treatment response.
By integrating psychedelic pharmacology, personalized brain stimulation, and multimodal neuroscience, this work aims to advance both treatment development and our understanding of how brain-based interventions can reduce problematic alcohol use.
Congratulations to Dr. Sayalı and the research team on this important achievement and exciting new direction for the Center.
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Next-Generation Psychedelic Drug Development
pubs.acs.org/acncdm/article/…
