Company: CMND
Filing Date: 2025-12-05
Form Type: F-1/A
Source: 0001213900-25-118772
Chunk: 138

Company: Clearmind Medicine Inc.
Filing Date: 2025-12-05
Form: F-1/A
Chunk 138
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 are often part of social networks, it is easy to understand how alcohol abuse has a ripple effect across a person’s entire network of family, friends, employers, colleagues, and anyone else who depends on the person. Reducing the problem for the patient will have a rebound effect, reducing the burden for the patient’s social circle as well. Lack of Therapeutic Innovation and New Treatments Historically, there has been a lack of innovation in new treatments and medicines for the treatment of alcohol related disorders. There are only three medications that are currently FDA-approved for the treatment of moderate to severe AUD: disulfiram, naltrexone (oral and long-acting injectable formulations), and acamprosate. Both naltrexone and acamprosate were associated with reduction in relapse to drinking. When directly compared with one another, no significant differences were found between acamprosate and naltrexone for controlling alcohol consumption. Disulfiram is used as a second-line treatment, behind acamprosate and naltrexone, for alcohol dependence. Based on results in open-label studies, disulfiram is a safe and efficacious treatment compared to other abstinence supportive pharmacological treatments or to no disulfiram in supervised studies for problems of alcohol abuse or dependence. In a meta-analysis conducted on disulfiram use with alcoholics in comparison to any alcoholic control group, it was concluded that blinded studies with disulfiram were incapable of distinguishing a difference between treatment and control groups. An additional drug, Nalmefene, 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