March 17, 2024

Three More States Introduce Psychedelics Bills, While FDA Sets MDMA Decision Date

Healthesystems has previously reported on the ongoing clinical research of psychedelic drugs for the treatment of mental health conditions, as well as the introduction of 10 bills in 2024 geared towards advancing psychedelic therapy across different states.

It appears that the momentum behind psychedelic advocacy will continue, as three more states have introduced bills involving psychedelics.

Connecticut House Bill 5297 would decriminalize the possession of psilocybin if less than half an ounce is possessed, resulting in a ticket and a $150 fine for a first offense, instead of a criminal charge. Repeat offenders would incur fines between $200-$500 and would be required to participate in a drug education program at their own expense.

Missouri House Bill 1830 would legalize the medical use of psilocybin in the state for patients aged 21 and older who suffer from PTSD, major depressive disorder, a substance use disorder, or who require end-of-life care. This bill would also mandate clinical trials exploring the therapeutic potential of the drug. Additionally, this bill would protect regulators, physicians, and state agency officials from legal consequences related to the use of psilocybin under the Act.

New Hampshire House Bill 1693 would permit and regulate the use of LSD, mescaline, and psilocybin to treat certain qualifying conditions, which include anxiety, depression, panic disorders, OCD, PTSD, social anxiety, body dysmorphia, anorexia nervosa, eating disorders, substance use disorders, sleep disorders, personality disorders, chronic pain, migraines and cluster headaches, and postpartum mental illnesses. The bill limits psychedelic possession to no more than two ounces, offering legal protections to those who do not exceed this limit.

In related news, the FDA has officially accepted for Priority Review the New Drug Application (NDA) for MDMA capsules in combination with psychological intervention for the treatment of PTSD. While this has been long coming, with the FDA working closely with researchers to expedite research, this latest action sets a decision date for MDMA’s potential clinical approval by August 11, 2024.

Additionally, the FDA has granted Breakthrough Designation to MM120, a formulation of the psychedelic LSD developed by MindMed, a biopharmaceutical company. 

MM120 is designed to treat generalized anxiety disorder. The FDA’s Breakthrough Designation accelerates the development and review process for new drugs that could significantly improve current treatments.

Clinical trials of MM120 showed meaningful and significant improvements when administered as a single does in a clinical setting, without additional therapeutic intervention. Due to the urgent need for anxiety treatments and its promising early results, the FDA has fast-tracked MM120's development. MindMed plans to start Phase 3 of its clinical trials in the second half of 2024.

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