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CURE Pharmaceutical gains DEA go-ahead to research psychedelics compounds

23 Mar 2021

MDMA, the main ingredient in ecstasy pills, in its pure form

Company will use extension of Schedule I licence to start development of psychedelics-based pipeline to treat mental health disorders

California-based drug development company CURE Pharmaceutical has gained US Drug Enforcement Agency (DEA) approval to conduct research on potential treatments for mental health disorders using the active compounds of illegal ‘psychedelic’ drugs such as LSD, ecstasy and magic mushrooms.

The company said on Tuesday it had secured an extension to its Schedule I DEA license that will allow it to conduct fully integrated research at its facility utilizing compounds such as LSD, MDMA, and psilocybin and its patented delivery platform, CUREform.

Previously the licence only allowed CURE to manufacture cannabinoid-based pharmaceuticals.

Schedule I licenses are granted to companies for the handling of drug substances with no accepted medical use and a high potential for abuse.

“Obtaining this type of license is a rigorous process, requiring a well-documented scientific investigation in a formal application, inspection of laboratory facilities and confirmation of facility security,” CURE said in a statement.

Rob Davidson, CEO of CURE said the license “will allow us to build out our previously announced psychedelics program safely and legally, expanding our specialty pharmaceutical pipeline and opening new doors to research advancement.”

Last year, CURE used the Schedule I license to complete a pharmacokinetic study of its preliminary 25mg cannabidiol (CBD) oral film showing improved bioavailability of CBD in healthy users when compared to 25mg soft gels. The study showed significantly higher serum concentration (Cmax) and significantly faster absorption (Tmax) comparing CURE’s CBD oral film dosage form to a commercially available CBD soft gel.

CURE said that further research on psychedelic compounds as potential mental health treatments has gained significant interest in last few years.

“There is promising research being conducted at the private, academic, and federal level on treatment of depression, PTSD, addiction disorders, obsessive compulsive disorder, and anxiety,” the company said.

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