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“By pursuing FDA approval of MDMA-assisted therapy first, we believe the learnings will be beneficial as we determine our regulatory strategy in the United Kingdom and Europe”, said Lykos CEO Amy Emerson.
“Hibadulin said his condition impeded his relationships and education, and that the only treatment that proved effective for him was psychedelic-assisted psychotherapy – a controversial method to cure PTSD illegal in Ukraine but used to a limited extent in some Western countries.”
Insights from the European Medicines Agency’s Psychedelics Workshop: A Pα+ Dispatch
Josh explores some of the key themes discussed at the workshop: from regulatory remits and rescheduling through to disentangling pharmacotherapy from psychotherapy, standardisation and its discontents, blinding, and much more.
“CEC is the first non-Christian church to receive protection for its spiritual practices regarding Ayahuasca.”
“Readers respond to a letter which said that MDMA is not helpful in mental health care”
“We respectfully request that you produce VA’s implementation plan that would be deployable as soon as this novel treatment option is approved for clinical use”, the letter reads.
Two new Rapid Response briefings from the UK Parliament’s POST look at the state of the evidence for psychedelics’ use in treating PTSD and eating disorders.
“A lobbying effort led in part by religious groups has state lawmakers considering two different measures that would legalize psilocybin, a drug known as “magic mushrooms.””
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“[Jules] Evans doesn’t advocate against psychedelics. But by exposing the hazards that tripping could involve, Evans hopes to temper the prevalent ethos of breezy optimism with a dash of caution.”
“From kava to “sleepy girl mocktails,” can anything ever take the place of booze?”
Josh sits down with Jaskaran (‘Jaz’) Singh, Vice President Psychiatry Development at Neurocrine Biosciences. For the purposes of this conversation, however, we focus on Singh’s role in spearheading the development of esketamine for treatment-resistant depression, now marketed as Spravato.
Here, 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.
“Arguably the buzziest area of research are psychedelic compounds. Long dismissed because of thorny legal and scientific issues, psychedelics are being taken more seriously as possible treatments for anxiety, depression and psychosis.”
The company’s pipeline includes SPT-348, “a prodrug of a non-hallucinogenic neuroplastogen in development for the treatment of mood and other neuropsychiatric disorders, [which] leverages Glyph to create a potential first-in-class treatment with improved pharmacokinetics and tolerability compared to conventional psychedelics.”
Jane C. Hu asks: Will legal psychedelics be any better?
Hu also appeared on Slate’s ‘TBD’ podcast on Sunday in an episode titled, Is America Ready for Legal Psychedelics?
A day-long LSD-assisted cycle event, Bicycle Day, will replace the ill-fated KAP discipline.
After two rounds of redundancies, a crack team of McKinsey consultants has made a somewhat unorthodox recommendation to federal agencies: LSD-assisted bureaucracy. A pilot program will be carried out at DMV offices.
Initial reports describe the experience, though lacking psychedelics’ characteristic subjective effects, as “heavy” and “somewhat unstable”, but “noticeably patentable”.
The company announced the claims cover its lead candidate, Polymorph Eau.
Fresh from a trip to Beijing, Yellen shares some of her favourite magical meals.
Fresh from a trip to the continent, Pollan takes on the final frontier of ineffability: mime.
The complaint alleges repeated failures to both capitalise and append ® to SPRAVATO®.
Sling darts at your favourite psychedelic drug candidates!
All over America, youths have been heard uttering “nar” with their mates on the way to brekkie at Macca’s.
In March, MindMed scored an FDA Breakthrough Therapy Designation for its LSD-D-tartrate candidate (MM120) for generalised anxiety disorder (GAD). In this piece, 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 broader ‘Spravato-isation’ of psychedelic therapies is stoking debate around the contribution of psychotherapy (or lack thereof) in these interventions.
“Charlotte Nichols, who has PTSD, says there is enough evidence to prescribe psilocybin therapy as mental health treatment”
Vicente LLP reviews the March 15th Colorado Natural Medicine Advisory Board meeting, where draft rules for Facilitator licensing and training were discussed.
Owing to some bizarre headlines from across the psychedelics space, we have compiled a special edition of our Psychedelic News Feed.
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