Synthetic cannabinoid drug trial planned for COVID-19

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A Philadelphia-based hemp company has joined the race to create a cure for COVID-19 using cannabinoids. In early June, FSD Pharma announced that the Food and Drug Administration (FDA) had approved the company’s application to conduct clinical trials of the drug. The treatment will use a drug called ultramicronized palmitoylethanolamide (or micro-PEA), which includes synthetic molecules that mimic cannabinoids.

Micro PEA is a unique preparation. It is believed to act as an anti-inflammatory and was approved from 1969 to 1979 in the former Czechoslovakia as a remedy for flu and colds. Clinical trials carried out at that time showed that PEA (Micro PEA) is an effective preventive agent for respiratory infections, and without reported side effects. According to the scientists who conducted the study, this could be a quick therapeutic response in the event of an epidemic.

Today, the drug is advertised as a prescription drug in Italy and is used to treat chronic inflammation. Pharmaceutical firm Epitech Group owned the rights to the drug and marketed it under the names Normast and Pelvilen. Earlier this year, FSD, headquartered in Toronto, Canada, acquired the worldwide rights from Epitech for $17.5 million and renamed it FSD-201.

“We contacted the FDA at the end of March 2023 after learning that several Italian doctors and scientists were advocating the use of ultramicronized PEA for patients suffering from COVID-19 symptoms based on the drug’s mechanism of action as a powerful and safe anti-inflammatory agent. an inflammatory agent that reduces the production of pro-inflammatory cytokines,” Philadelphia physician and FSD CEO Raza Bohari said in a statement.

In an interview with The Philadelphia Inquirer, Bohari emphasized that the FSD does not claim that cannabinoids, whether synthetic or plant-based, are an alternative for treating COVID-19. But the CEO said that FSD-201 modulates the endocannabinoid system like a “natural fatty acid” by acting on CB2 receptors, which are thought to influence pain and inflammation in humans.

“Severe COVID-19 is characterized by an excessive inflammatory response that can lead to a cytokine storm,” Bohari told the Inquirer. “[FSD-201] is not a killer virus. But we think it could moderate this immune response, which can be fatal.”

Previous research published in Preprints suggested that marijuana could manipulate the major cellular gates that COVID-19 enters the system. The researchers wrote that the new cannabinoid combination “could be a useful adjunct to COVID-19 treatment.” Israeli researchers have also begun clinical trials as to whether marijuana terpenes can affect and/or prevent COVID-19.