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August 19 – 25, 2024
Natural Medicine Advisory Bulletin 13.5: The Birth of a Regulated Psychedelics Program
Psychedelic Alpha ↗
A must-read for anyone considering operating a Natural Medicine Business, or becoming a Facilitator, in Colorado’s state-regulated psychedelics program.
‘From LA to Byron to Sydney’: The trippy treat popular among Millennial mums
The Sydney Morning Herald ↗
August 12 – 18, 2024
Pα+ Psychedelic Bulletin #170
Psychedelic Alpha ↗
- MindMed Tops Up Healthy Cash Balance with $75M Raise; Eyes Adding Depression to Pipeline?
- atai Approaches Phase 2 for DMT and R-MDMA Candidates
- Compass’ Phase 3 Program Generally On-Track, Potential for Slight Delay on Readout
- European Psychiatrists Remain Open to Psychedelics, Research
- Other Stories, including: Cybin’s Phase 3 plans; AbbVie’s $8.7bn neuropsych acquisition; Otsuka’s DTx pricing; Intra-Cellular Therapies’ preferred non-hallucinogenic lingo; Gilgamesh’s Fierce 15 spot; Incannex’s green light from FDA; and more.
Q&A: Lykos just cut 75% of its workforce after an FDA rejection. Here’s what the CEO has to say
Endpoints ↗
Endpoints puts some tough questions to Lykos CEO Amy Emerson.
OPEN WAR As FDA BLOCKS MDMA Therapy For Vets
YouTube (Breaking Points) ↗
In a fiery interview, Jonathan Lubecky goes toe-to-toe with former Psymposia Managing Editor David Nickles.
FDA’s Rejection of MDMA for PTSD Could Signal Setback for Psychedelic Industry
Behavioral Health Business ↗
Lykos Plots FDA Appeal: Reeling from CRL and Journal Article Retractions, MDMA Developer Hopes to Change Your Mind
Psychedelic Alpha ↗
Josh delves into FDA’s appeal process with regard to Lykos Therapeutics’ development program, and covers the trio of journal article retractions that have cast another shadow over the company’s published studies. Plus: We assess the fallout beyond Lykos, as psychedelic drug developers wrestle over the role of psychotherapy in their protocols, fast followers assess their strategies, and would-be psychedelic therapy delivery companies face a substantial delay.
What to know about the 5 people charged in Matthew Perry’s death
AP News ↗
A prosecutor says five people have been charged in connection with Matthew Perry’s death from a ketamine overdose last year, including the actor’s assistant and two doctors.
Recruiting healthy participants for London-based psilocybin study
The Digital Intervention for Psychedelic Preparedness (DIPP) study ↗
If you have 3-5 lifetime psychedelic experiences, minimal meditation experience, and can commit to a 21-day prep course with visits to UCL over a 4-week period, researchers would like to hear from you.
August 5 – 11, 2024
BREAKING: FDA Rejects Lykos Therapeutics’ MDMA-Assisted Therapy For PTSD
Psychedelic Alpha ↗
FDA has issued a Complete Response Letter (CRL) to Lykos Therapeutics regarding its New Drug Application (NDA) for MDMA-assisted therapy in PTSD, meaning the agency is not prepared to approve it at this time.
Read our breaking coverage for more.
Vibe Check: FDA Set to Decide Future of MDMA-Assisted Therapy This Week
Psychedelic Alpha ↗
With a target PDUFA date of August 11th, FDA is expected to make a decision on Lykos Therapeutics’ MDMA-assisted therapy for PTSD New Drug Application (NDA) at some point this week.
As we brace for a deluge of mainstream media coverage and insider reactions, Josh takes the opportunity to provide a brief assortment of notes and thoughts.
Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD
Lykos Press Release ↗
The story has been widely covered in major outlets, including:
Three Lykos-Affiliated Studies Retracted
↗
The journal Psychopharmacology has issued three retraction notices for MAPS/Lykos’ meta-analysis of phase 2 studies of MDMA-assisted therapy for PTSD, which constituted the rationale for a Phase 3 program. The first retraction pertains to the pooled analysis of the half-dozen phase 2 studies (Mithoefer et al., 2019), the second relates to the long-term follow-up of those six trials (Jerome et al., 2020), and the third applies to an analysis of four of the phase 2 studies to explore the effect of tapering antidepressants (Feduccia et al., 2020).
When Ollie took a pill, he didn’t realise it would be a ‘never-ending trip’
The Sydney Morning Herald ↗
July 29 – August 4, 2024
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