Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed.
PharmaTher Announces Positive FDA Meeting; Path Towards Phase 3 Trial
PharmaTher continues to move its niche ketamine programs through the FDA process. The company announced a positive FDA meeting and guidance for an upcoming Phase 3 trial. This news is regarding its KETARX (ketamine) treatment for dyskinesia in Parkinson’s disease, a program that already produced positive Phase 2 results.
Massachusetts Bill Would Cap MDMA Therapy Costs at $5,000
“Any person or entity registered to prescribe, manufacture, distribute, dispense or provide services related to 3,4-methylenedioxymethamphetamine (MDMA) shall not charge more than $5,000 per MDMA treatment service unit.” This is the language used in bill HD2137, filed by Massachusetts State Representative. Nick Boldyga, a Republican, has proposed a bill that would not only re-schedule MDMA automatically upon FDA approval but cap the cost of treatment at $5,000.
Albert Labs announces Strategic Investment from Cantheon Capital
- Cantheon Capital, one of the largest global pharmaceutical psychedelics venture capital firms, sign terms for ~CA$830,000 (£500,000) of funding to Albert Labs
- Albert Labs’ first human trials, due to commence in Q2 2023, will be carried out in partnership with industry leading clinical research partner, iNGENu.. The trials will take place in Australia, providing the Company with the additional benefit of access to a 43.5% cash reimbursement on all eligible related costs equating to a further benefit of ~CA$1.2 million
Revive Therapeutics Provides Update on Psilocybin Clinical Study for Methamphetamine Use Disorder
Revive provides an update on the company’s Phase I/II clinical study evaluating the safety and feasibility of oral psilocybin as a potential treatment for methamphetamine use disorder conducted at the University of Wisconsin-Madison, School of Medicine.
The Study has enrolled its first patient and initial results are expected in Q3-2023.
Apex Labs Meets Endpoints in First-of-its-Kind Take Home Microdose Psilocybin Clinical Trial
“This clinical milestone cements APEX as the first mover in take home psilocybin treatment and furthers our commitment to treating the substantial unmet need within the Veteran community,” says APEX CEO Tyler Powell. “Following our recent approval for the world’s largest take home microdose clinical trial, STEP-52 confirms we are on the right track towards demonstrating efficacy of this new drug in pivotal clinical trials.”
STEP-52 was approved by Health Canada in October of 2022, commenced January of 2023, and patient dosing was completed March 29th, 2023.
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