Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed
FDA Issues First Draft Guidance on Psychedelic Clinical Trials
The FDA has published new guidance for researchers investigating the use of psychedelic drugs for the treatment of medical conditions, including psychiatric or substance use disorders. This is the first FDA draft guidance that presents considerations to industry for designing clinical trials of psychedelic drugs.
Mindset Pharma Receives Approval for Phase II Depression Trial
Mindset Pharma has been granted approval to start a Phase 2 trial for Major Depressive Disorder, using their lead drug candidate MSP-1014.
MSP-1014 is a novel prodrug of psilocin, the active metabolite of psilocybin, and is “anticipated to exert similar efficacy to psilocybin in improving symptoms of depression. Preclinical studies comparing MSP-1014 to psilocybin suggest that the tolerability of MSP-1014 may be superior to psilocybin.”
Toms Shoes Founder Pledges $100 million for Psychedelic Research
Blake Mycoskie, founder of Toms Shoes, has pledged to give $100 million to support psychedelic research and access.
Mycoskie said the money will help fund research, support academic institutions studying psychedelic medicine, and nonprofits working to increase access for patients in need of psychedelic treatments.
PharmaTher and Vitruvias Enter Into Commercialization Agreement for KETARX™ in the US
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PharTher has announced a collaboration agreement with Vitruvias Therapeutics for the commercialization of its KETARX (racemic ketamine) products in the U.S.
The company also gave an update on its expected timeline, with PharmaTher expecting to file its abbreviated new drug application (“ANDA”) for KETARX™ (racemic ketamine) with the FDA in early July, and obtain FDA approval in Q1-2024 — with anticipated potential commercial launch of KETARX™ in Q2-2024.
USFDA Approves LaNeo MDMA for Clinical Trial Use in the United States
The US Food and Drug Administration (USFDA) has approved a clinical trial utilizing PharmAla’s LaNeo MDMA Investigational Medical Product (IMP) capsules (40mg). This is the first time that PharmAla’s IMP has been approved for trial use in the United States.
