Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 113

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 113
---
ene, is approved for AUD treatment in Europe, but is not currently available in the United States. According
to a meta-analysis, the drug is able to improve behavioral outcomes in patients with AUD, while others show that it has a limited efficacy
in alcohol dependence therapy, and rather, it is more useful as an as-needed, harm-reducing pharmacotherapy.

There are other medications that are used off-label
for AUD including gabapentin, topiramate, baclofen, and ondansetron For most medications used off-label, evidence was either insufficient
to determine whether they are associated with reduced consumption or evidence suggested that they are not (Jonas et al., 2014).

Most well-controlled trials of disulfiram do not
show overall reductions in alcohol consumption. However, psychedelics seems to emerge as a potential new treatment. An increasing validation
of preclinical clinical and regulatory studies of new psychedelics pharmacological classes have been approved by the FDA. This combination
of market opportunity and recent advances signal an increased acceptance of these novel approaches, and we believe we are well positioned
to capitalize on this potential opportunity.

In May 2021, Nature Medicine published findings
from a first Phase 3 clinical trial conducted with psychedelic-assisted therapy. The study found that MDMA combined with psychological
counseling yielded “marked relief to patients” with severe PTSD. Based on the Phase 3 clinical trial results, MAPS Public
Benefit Corp. recently filed an application with the U. S. FDA to approve the psychedelic drug MDMA - also known as Ecstasy - 
in combination with therapy to treat PTSD. The filing is a milestone in researchers’ quest to move psychedelic drugs from tightly
restricted substances into mainstream medical treatments that are widely accessible to patients. This comes after decades of studies have
demonstrated the promise of psychedelics to treat mental health disorders.

Esketamine was approved by the FDA on March 5,
2019, for treatment-resistant depression. It is sold under the trade name, Spravato. Esketamine became the first FDA-approved psychedelic
treatment for a psychiatric disorder. In addition, recently the FDA extended its approval for esketamine to adults with major depressive
disorder with acute suicidal ideation or behavior. In April 2021, the FDA granted psilocybin “breakthrough” therapy designation.
In addition, the FDA cleared MAPS (Multidisciplinary Association for Psychedelics Studies) to conduct Phase III