Psychedelic Treatments Quickly Nearing U.S. FDA

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Psychedelic Treatments Quickly Nearing U.S. FDA Approval
Tue May 26, 2020

Houston, Texas--(Newsfile Corp. - May 26, 2020) - Psychedelic drugs have been written off for years.

But that's quickly changing as multiple studies prove its effective in the treatment of mental and health related issues.

For example, in recent months, Johns Hopkins Medicine announced the launch of the Center for Psychedelic and Consciousness Research to study compounds like LSD and psilocybin to treat a range of mental health problems, including anorexia, addiction and depression. Psychiatrists at Johns Hopkins University even found that mushrooms can help with smoking cessation, and another study found it can assist with alcohol dependence.

Methyl​enedioxy​methamphetamine (MDMA), or what's commonly known as ecstasy, could be approved by the US FDA by 2022 following successful Phase III trials.

Three years ago, the US FDA gave "breakthrough therapy" status to MDMA for the treatment of post-traumatic stress (PTSD). Nowadays, the Multidisciplinary Association for Psychedelic Studies (MAPS) says they're seeing big success with their Phase III trials of MDMA in the treatment of PTSD.

In fact, according to MAPS Founder, Rick Doblin, "The results of the interim analysis of MAPS' pivotal first Phase 3 trial are the most powerful evidence yet that MDMA-assisted psychotherapy could help transform the lives of people suffering from PTSD."

Aside from PTSD, depression, anxiety, obsessive compulsive disorder, and chronic pain, Yield Growth Corp. (BOSQF) (CSE: BOSS) (OTCQB: BOSQF) subsidiary NeonMind Biosciences Inc. is nearing studies to confirm whether it's an effective treatment for obesity, too.

Psilocybin May Even Help Address the Global Obesity Epidemic

NeonMind Biosciences Inc. has taken further steps towards commencing its clinical studies to confirm whether psilocybin (a compound in psychedelic mushrooms) is an effective treatment for food cravings and weight loss. NeonMind has now identified a source of psilocybin in Canada and has identified a laboratory at a University in Canada in which to conduct the studies.

NeonMind previously announced that it had engaged Translational Life Sciences Inc. to conduct the study and that TLS had completed the design of a study to confirm whether psilocybin (found in psychedelic mushrooms) is an effective treatment for weight loss and food craving.

TLS has identified a source of synthetically created psilocybin, manufactured by a licensed laboratory, for use in the NeonMind studies. Also, NeonMind has identified a laboratory where the studies can be carried out. Before the psilocybin can be ordered and before NeonMind can enter into an agreement with the Lab, the Lab must first obtain an exemption from the Canadian Minister of Health pursuant to Subsection 56(1) of the Controlled Drugs and Substances Act, S.C. 1996, c. 19 by the researchers at the Lab to allow them to use psilocybin, a controlled substance, in research studies. NeonMind expects the exemption to be granted within a few months. Researchers at the Lab have previously obtained other exemptions for research involving controlled substances.

TLS has provided an estimate of $250,000 as a budget for the study and an estimated time frame of 6 months to complete the study, with valuable data anticipated to be available within the first few months. TLS estimates that all necessary approvals can be obtained so that the study can commence in the fall of 2020. NeonMind plans to fund the study using previous capital raised and from the proceeds of a planned initial public offering of NeonMind, for which due diligence is currently underway with a Canadian investment dealer.

According to the terms of the TLS engagement, signed on May 6, 2020, NeonMind and TLS agreed to work together to conduct the evaluation of psilocin or psilocybin on cravings, on the metabolism, on food addiction and on glucose and hormone levels. Neon authorized TLS to perform activities required to prepare for and conduct the study and the parties shall work towards entering into a clinical study agreement. NeonMind agreed to pay for all costs related to the study and TLS agreed to arrange for required regulatory exemptions and licenses, and engagement of all necessary parties to conduct the study.

The company hopes to tap into multi-billion-dollar market opportunities, including the $245 billion weight loss and management market, $64 billion cardiovascular disease treatments, the $156 billion depression market, and the $87 billion diabetes treatment market.

For more information, visit the company's website at https://yieldgrowth.com.

https://seekingalpha.com/pr/17881127-psychede...a-approval

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