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FDA Issues Draft Guidance for Testing Psychedelics as Mental Health Treatments

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The Food and Drug Administration recently released a draft guidance on research protocols for psychedelic substances. This move signals the probable use of these drugs as treatments for mood disorders such as post-traumatic stress disorder and depression.

In a statement, Dr. Tiffany Farchione, who oversees the regulation of psychiatric medicines at the FDA, stated that psychedelics had shown promise as possible therapies for anxiety, substance use and mood disorders and added that they were still at the investigational stage. Farchione noted that the agency hoped to outline the issues that arose when developing psychedelic drug-development programs.

The draft guidance, she continued, would offer more information on how to address the aforementioned issues and assist researchers in designing studies to support future drug applications. Issues that arose when designing clinical studies to evaluate the effectiveness and safety of psychedelics included alterations in consciousness that lasted for hours and managing to build trials around substances that caused acute disturbances in perception.

These last few years, we have seen psychedelic-assisted therapy increase in popularity, despite the fact that drugs such as MDMA, ayahuasca and psilocybin are still illegal. Currently, the drugs remain classified as Schedule I drugs, together with others such as marijuana and heroin. Drugs under this classification are said to have a high potential for abuse and no accepted medical use.

This may soon change, however, with experts suggesting that MDMA may gain approval to treat mood disorders as early as 2023. This follows findings from early trials involving the administration of psychedelics in conjunction with other therapies, which demonstrated improvements in individuals suffering from mood disorders.

Some analysts expect that by 2029, the global market for psychedelics will have surpassed $11 billion as more financial backers jump on the bandwagon. Last week, New York Mets owner and hedge fund manager Steve Cohen donated $5 million for research on the benefits of ecstasy in the treatment of post-traumatic stress disorder.

However, while the NIH states that these substances may boost growth of new neuron connections in the brain, the agency also highlights that their mechanism of action is still unclear.

Regulators are set to discuss the draft FDA guidelines in August, with the agency underscoring the importance of the requirements researchers must adhere to when conducting trials using these substances.

At the moment, more than 100 clinical trials are administering psychedelic substances as medicine, with some recruiting volunteers in Canada and the United States to take part in the trials. The participating entities include Mind Medicine Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ).

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