atai Life Sciences Announces Positive Initial Results for Phase 1 Trial of KUR-101, an Oral Formulation of Mitragynine for OUD
atai Life Sciences has announced positive initial results for their Phase I clinical trial of KUR-101
Archives: news
Mindset Pharma Announces Development of Novel, Optimized, Intranasal Formulation
Mindset Pharma has announced that it has developed a novel, patent-pending, intranasal platform formulation technology expected to deliver improved central nervous system (CNS) penetration of first and subsequent generations of psychedelic medicines. The proof of concept of this novel formulation demonstrates improved CNS penetration compared to standard formulations of 5-MeO-DMT.
First-of-its-kind MDMA group therapy trial set to commence
A first-of-its-kind trial exploring MDMA-assisted therapy in a group setting being led by MAPS is about to commence following the resolution of a clinical hold placed by the US Food and Drug Administration (FDA) that paused progress for several months.
Congressional Leaders Urge Psychedelics Research For PTSD And Depression In Updated Spending Measures
Congressional interest in psychedelics continues as a manager’s amendment to legislation covering the Department of Health and Human Services contains two sections addressing the therapeutic potential of psychedelics.
Federal Health Officials Say Psychedelics’ Illegal Status Makes It Harder For Researchers To Study Them
Officials at two agencies within the National Institutes of Health (NIH) have acknowledged in a letter to two U.S. senators that federal prohibition makes it harder to study the benefits of psychedelics, requiring researchers to jump through additional regulatory hoops.
Novel PTSD Treatment Advances Toward Regulatory Evaluation with New Collaboration
MAPS Public Benefit Corporation (MAPS PBC) announced today that it has selected the contract research organisation (CRO), MMS Holdings (MMS), as its CRO for the development of a New Drug Application (NDA) for MDMA-assisted therapy for PTSD. MMS will support the NDA submission by providing regulatory strategy, biostatistics, statistical programming, medical writing, medical review, publishing, and submission project …
A Psychedelic Renaissance at the V.A.
Psychedelics’ latest feature in The New York Times explores the work of four Veterans Affairs clinicians, frustrated with existing treatments for addiction and PTSD, and have turned to psychedelic medicine to help veterans get the treatment they need.
Cybin Receives FDA IND Clearance for its Phase 1/2a Clinical Trial Evaluating CYB003 for the Potential Treatment of Major Depressive Disorder
Cybin has announced that it has received a “may proceed letter” and Investigational New Drug Application clearance from the U.S. FDA for its Phase I/IIa first-in-human clinical trial evaluating CYB003. CYB003 is a proprietary deuterated psilocybin analogue that is being developed for the potential treatment of major depressive disorder. This milestone marks the industry’s first-ever …
Enosis Therapeutics Generates Positive Results from World’s First Study of the Synergistic Application of Virtual Reality and Psychedelics
Enosis Therapeutics has announced the successful completion of the world’s first study on the synergistic application of VR and psychedelics. The study, led by researchers and co-founders of Enosis Therapeutics, Agnieszka Sekula and Prash Puspanathan, was conducted in the Netherlands and in collaboration with Swinburne University of Technology and the Psychedelic Society Belgium.
U.S. FDA Clears MYCO-001 for Multi-Site Government Funded Trial in Smoking Cessation
Mydecine has announced that the U.S. Food and Drug Administration has cleared MYCO-001 in a recent Investigational New Drug (IND) application, marking the first clearance of the company’s drug product.