Vicente LLP Psychedelics & Emerging Therapies Update: December 2023
Dec 19, 2023
State News & Insights
MAPS PBC Announces Submission of New Drug Application to the FDA for MDMA-Assisted Therapy for PTSD
MAPS Public Benefit Corporation (MAPS PBC), a company focused on innovative mental health treatments, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for MDMA-assisted therapy for post-traumatic stress disorder (PTSD). This marks a significant milestone in the development of psychedelic-assisted therapies and could potentially lead to the first FDA-approved treatment of its kind. Read the press release.
Colorado Natural Medicine Health Act Tracker Produced by Vicente LLP and Psychedelic Alpha
Colorado's Natural Medicine Board raced against the clock in November, grappling with dose limits, outdoor cultivation, and data privacy while drafting the state's first regulated natural medicine program. Concerns arose about restricted microdosing and spiritual experiences, excluded outdoor growers, and balancing research with individual rights. Despite delays and open questions, the program edges closer to reality. Read the latest bulletin here.
Join the Movement to Support Safe, Equitable Access to Psychedelic Medicines in Colorado
Healing Advocacy Fund Colorado (HAF) exists to support safe, equitable and effective implementation of the Natural Medicine Health Act, with the hope that Colorado can serve as a model for thoughtful and ethical reform. Grounded in values of safety, inclusivity, equity and responsibility, the organization intends to foster opportunities for community participation as this implementation journey unfolds.
- Sign up for HAF’s newsletter for news, updates, events and research around the implementation of the NMHA
- Interested in being a part of the Proposition 122 Implementation Coalition? Fill out this brief survey from HAF
- Donate to HAF. Your charitable donation supports safe, equitable access to psilocybin therapy for those who need it.
The Psilocybin Research Pilot Program proposed by Wisconsin lawmakers would study the effects of psilocybin on veterans with PTSD at the University of Wisconsin-Madison. Veterans who are 21 and older with diagnosed treatment-resistant PTSD would be eligible to participate in the program. According to Marijuana Moment, the bill would create a medicinal psilocybin treatment fund to support the research, with an initial infusion of $100,000 in appropriations.
Washington State Psilocybin Bill Heads to Governor's Desk
Washington State's Senate Bill 5263 would create a Psilocybin Advisory Board, an Interagency Psilocybin Work Group, and a Psilocybin Task Force, according to High Times. The bill would also establish a pilot program at the University of Washington to provide psilocybin treatment to veterans with PTSD or mood/substance use disorders.
Federal News & Insights
A proposed amendment to a major spending bill would prohibit the use of federal funds to interfere with state and local laws that permit the use and sale of psilocybin for medical purposes. Representatives Robert Garcia (D-CA) and Earl Blumenauer (D-OR) are advocating for the inclusion of the psychedelics measure in appropriations legislation covering Commerce, Justice, Science, and Related Agencies (CJS). The amendment has garnered support from various organizations, including the Drug Policy Alliance and the American Civil Liberties Union. These organizations maintain that the amendment is crucial to safeguarding states' rights and enabling responsible psilocybin regulation.
Federal Appeals Court Rules Against DEA In Psilocybin Rescheduling Lawsuit Brought By Doctor Who Wants To Give Psychedelic To Cancer Patients
A federal appeals court ruled against the Drug Enforcement Administration (DEA) in a lawsuit filed by a Washington State doctor seeking to reschedule psilocybin. The court determined that the DEA failed to adequately explain its reasoning for denying the rescheduling petition and ordered the agency to provide a more thorough justification.
The Drug Enforcement Administration plans to increase production quotas for delta-9 THC and other cannabinoids, as well as high levels of psychedelics, for research purposes. This is due to the growing interest in these substances for medical and therapeutic purposes. Specifically, DEA is proposing to increase the manufacturing quota for psilocybin by 40%, from 120,000 grams to 168,000 grams.
The National Institutes of Health (NIH) is soliciting proposals for research on the potential of psychedelics to treat substance use disorder (SUD). The agency plans to allocate $2 million in grant funding for these projects during the fiscal year 2025.
The funding opportunity will support research on a variety of psychedelic substances, including classic psychedelics like psilocybin and LSD, empathogens like MDMA, dissociatives like ketamine, and other hallucinogens like ibogaine and its derivatives. The proposal application period will be open from January 28 to February 28, 2024. Read more on Marijuana Moment.
FDA recently released guidance related to the potential risks associated with the at-home use of compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders. Patients and healthcare providers should be aware that the FDA has identified potential safety concerns and the FDA encourages compounders, patients, and healthcare providers to report adverse events associated with compounded ketamine products to FDA’s MedWatch Adverse Event Reporting program.
Miscellaneous News & Insights
Support the Cause!
Non-profit organizations Reason for Hope and the Veteran Mental Health Leadership Coalition (VMHLC) are leading a coordinated federal and state advocacy strategy to accelerate access to psychedelic "Breakthrough Therapies" for suicide prevention, specifically for the treatment of PTSD, treatment-resistant depression, and major depressive disorder. These organizations are supporting the BTA. One way you can support the cause is by donating to Reason for Hope or VMHLC.
Events
January 10-15 | Costa Rica Psychedelics Investor Event
Vicente LLP partners Sally Kent Peebles and Shawn Hauser are slated to speak at a psychedelic retreat in Costa Rica hosted by Harmony Nosara from January 8-15, 2024. Sally and Shawn will discuss and analyze core issues shaping the psychedelics ecosystem.
February 27 | Vicente LLP Hosted Denver Psychedelics Event
What can we expect for the future of psychedelics from the upcoming legislation session? Join Joshua Kappel and other members of Vicente's psychedelics team on February 27 for a deep dive into everything psychedelics reform. Stay tuned for more info!
Resources
To access Psychedelics & Emerging Therapies-related legislative summaries, regulatory updates, licensing information, informational webinars and events from Vicente LLP, simply bookmark this webpage.