Weekly Psychedelic News – Week 20, 2023

Stay up-to-date with the latest in the world of psychedelics with our weekly news roundup for week 20 of 2023. Read about the latest research, policy updates, and industry developments in the rapidly growing field of psychedelic science.

PharmAla Biotech and Shaman Pharma Received Authorization to Provide MDMA Capsules to a Canadian Physician for Treatment of a Patient.

PharmAla Biotech Holdings Inc. and Shaman Pharma, have received authorization from Health Canada to provide LaNeo MDMA capsules for the treatment of a patient under the Special Access Program. This marks the first-ever authorization of MDMA-assisted therapy treatment under this program. The companies will not charge the patient or physician for the drug product

β€œIt’s absolutely thrilling to be able to say that our GMP LaNeo MDMA will be used for the treatment of a patient in Canada. Ultimately, that’s what all of our work should be about: improving lives for patients.” said Nick Kadysh, CEO of PharmAla.

Mind Medicine Australia to Supply Psilocybin and MDMA at No Cost for New Innovative Clinical Trials

Mind Medicine Australia (MMA), a registered charity dedicated to advancing psychedelic-assisted therapies, has successfully advocated for the rescheduling of psilocybin and MDMA by the Therapeutic Goods Administration (TGA) in Australia. This landmark decision allows authorized psychiatrists to prescribe these medicines for patients with treatment-resistant depression (psilocybin) and treatment-resistant post-traumatic stress disorder (MDMA) starting from July 1, 2023. Australia has become the first country in the world to take this step, thanks to MMA’s evidence-based applications and extensive advocacy efforts.

To ensure the availability of these medicines, MMA has entered into an agreement with Canadian manufacturer Optimi Health Corp for the supply of GMP medical-grade psilocybin and MDMA. This partnership will ensure affordable access to these medicines in Australia. MMA also actively supports ongoing and new research on psychedelic medicines in mental health treatments and is currently funding or co-funding four different trials. Furthermore, MMA’s representations and advocacy efforts led to the Commonwealth Government announcing a $15 million grant round to support psychedelic medicine research, the largest government grant of its kind worldwide.

In an effort to expand the research base, MMA invites research organizations to apply for the supply of GMP medical-grade psilocybin and MDMA at no cost to support new clinical trials. MMA is particularly interested in supporting trials that enhance treatment outcomes and explore the application of these therapies to other mental and physical illnesses, aiming to advance knowledge and understanding in this field.

NC House Committee Advances Bill That Supports Psychedelic-Assisted Therapy

A bill in North Carolina’s House committee has moved forward, proposing funding for research initiatives focused on “breakthrough therapies” involving psychedelic substances such as MDMA and psilocybin. While the measure does not legalize these psychedelics, it aims to provide competitive grants through the state Department of Health and Human Services (HHS) for eligible research entities and academic institutions capable of conducting studies, including clinical trials with adults.

If passed, the bill would require the department to accept grant applications starting in August 2024 and fund three years of research. Recipients would be expected to adhere to FDA protocols and applicable federal law and submit a report of their findings and recommendations by January 15, 2028. The Breakthrough Therapies Research Advisory Board and the health department would oversee the selection of two grant recipients, each receiving $2.5 million, and inform a joint legislative committee about their selection.

Federal Agency Announces Funding for Research on Psychedelics to Treat Drug Addiction

National Institute on Drug Abuse (NIDA) Offers $1.5 Million Funding for Psychedelic Research on Treating Substance Use Disorders.

The National Institute on Drug Abuse (NIDA), a federal health agency, has announced its intention to allocate $1.5 million in funding for research initiatives exploring the potential of psychedelics in treating substance use disorders (SUDs). NIDA published three notices of funding opportunities (NOFOs), inviting proposals to investigate the therapeutic effects of substances like psilocybin and ayahuasca on individuals with SUDs.

The NOFOs outline the primary objective of the research as understanding the mechanisms of psychedelics and conducting clinical trials involving human subjects. NIDA emphasizes the need for modern neuroimaging and behavioral analytic tools to uncover the neurobiological and behavioral changes induced by psychedelics, with the aim of identifying key adaptations that lead to symptom improvements and designing effective psychedelic therapies.

The agency poses several questions that it hopes the research will address, such as the specific cognitive constructs affected by psychedelics in SUD treatment, the underlying neurobiological changes facilitated by these compounds, and the effects on brain networks and circuits relevant to SUD. NIDA also seeks to determine the temporal trajectories of neurobiological, cognitive, and behavioral effects, as well as the replicability of neuroplastic effects observed in animal studies.

The funding, distributed through four awards, will support research projects in the 2024 Fiscal Year. Eligible applicants include universities, non-profit organizations, for-profit businesses, state and local governments, and federal agencies. NIDA’s initiative reflects growing public interest in the therapeutic potential of psychedelics and underscores the need for empirical evidence to advance the field and develop effective treatments for substance use disorders.

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