27 March 2023 - - Canada-based biopharmaceutical company FSD Pharma Inc's (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) Australian entity, FSD Pharma Australia Pty Ltd. received the certificate of approval from The Alfred Ethics Committee in Australia to proceed with a Phase 1 clinical trial of Lucid-201 as a novel drug candidate for the potential treatment of Major Depressive Disorder, the company said.

Lucid-Psych is being developed outside of Australia by Lucid Psycheceuticals, Inc., a wholly owned subsidiary of FSD Pharma, and in Australia by FSD Pharma Australia Pty Ltd
Lucid-Psych is a psychoactive molecule selected as a potential therapeutic for MDD based upon the compound's pharmaceutical and metabolic properties including employing machine learning algorithms, as well as for its potential proprietary position.

Major Depressive Disorder, sometimes called clinical depression, is a serious mental health disorder categorized by feelings of sadness or worthlessness, depressed mood, lack of motivation, and anhedonia, or reduced interest in activities once considered enjoyable.

MDD can be a chronic condition with multiple periods of regression and relapse over a lifetime.

Different types of MDD include Seasonal Affective Disorder, Postpartum depression, psychotic depression, melancholic depression, and catatonic depression.

Broadly speaking, the National Institute of Health considers depression one of the most common mental disorders in the United States.

An estimated 21.0 m adults in the US had at least one major depressive episode in 2020, representing 8.4% of the country's adults. In the same year, an estimated 4.1m adolescents aged 12 to 17 in the US had at least one major depressive episode, representing 17% of people in the age group.

According to Allied Market Research, the global antidepressant drugs market size was valued at USD 15.65bn in 2020 and is projected to reach USD 21bn by 2030.

FSD Pharma Inc. is a biotechnology company with three drug candidates in different stages of development.

FSD BioSciences, Inc., a wholly owned subsidiary, is focused on pharmaceutical research and development of its lead compound, FSD201, a proprietary ultra-micronized PEA formulation, for the treatment of inflammatory diseases.

Lucid Psychss Inc., a wholly owned subsidiary, is focused on the research and development of its lead compounds, Lucid-Psych and Lucid-MS.

Lucid-Psych is a molecular compound identified for the potential treatment of mental health disorders, and expanding this category, the company is investigating other products addressing acute medical needs due to the abuse of drugs such as alcohol.

Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders.