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Psychedelic Business Briefs: COMPASS Pathways, MAPS PBC, Delix Therapeutics
AMA to Issue New Code for Psychedelic Therapies
COMPASS Pathways and MAPS Public Benefit Corporation announced recently that the American Medical Association (AMA) has approved a current procedural terminology (CPT) III code for psychedelic therapies. Full details of the code are expected to be released by the AMA in July, and the code is slated to go into effect on January 1, 2024.
The new CPT code will provide healthcare providers a means to obtain reimbursement for delivering psychedelic therapies. Application for the code was the result of a collaboration between COMPASS Pathways and MAPS PBC to facilitate reimbursement and, ultimately, access to psychedelic therapies in the US, if approved by the Food and Drug Administration (FDA).
COMPASS Pathways is currently conducting a phase 3 program of its investigational COMP360 psilocybin therapy in treatment-resistant depression. MAPS PBC, meanwhile, has completed 2 phase 3 clinical trials evaluating MDMA-assisted therapy as a potential treatment for post-traumatic stress disorder. The new CPT III code could provide a mechanism by which the treatments being developed by the 2 organizations could be reimbursed if they are approved by the FDA.
“This is a major step forward to enabling broad and equitable access to psychedelic therapies,” COMPASS Pathways CEO Kabir Nath said in a news release. “This collaboration with MAPS PBC to develop a new CPT code aims to ensure that psychedelic therapies, if approved, could be integrated into healthcare systems, reimbursed by payers, and made available to the people who need them.”
Delix Initiates Phase I Trial for Novel Compound
Delix Therapeutics announced on Tuesday that it has received regulatory approval and initiation of recruitment for a phase I clinical trial of DLX-001, a nonhallucinogenic psychoplastogen. DLX-001 becomes the first of psychoplastogens being developed by Delix to be approved for human trials.
The trial will enroll about 100 healthy volunteers, and it is being designed to assess safety, pharmacokinetics, psychometric functions, and markers of brain activity and synaptic plasticity. The trial will be conducted at the Center for Human Drug Research in the Netherlands.
“With the continued rise of mental health diagnoses across the globe and a significant lack of innovative treatment options available for those suffering, we are excited about the potential of psychoplastogens—especially scalable non-hallucinogenic compounds—to treat a variety of conditions as safe and effective take-at-home medicines,” Delix CEO Mark Rus said in a news release.
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