Philadelphia, Pennsylvania-based cannabis company FSD Pharma has been granted permission by the Food and Drug Administration to submit an Investigational New Drug Application for a clinical trial using a synthetic cannabinoid drug called ultramicronized palmitoylethanolamide (micro PEA) to treat COVID-19.
The drug is believed to act as an anti-inflammatory and is currently sold in Italy and Spain as a prescription-based nutraceutical under the brand names Normast and Pelvilen. FSD acquired the rights to micro PEA from Epitech Group, an Italian pharmaceutical firm that holds the patents for the drug until 2034, the company said.
In a press release, FSD explained that between 1969 and 1979, PEA was marketed as Impulsin by a pharmaceutical manufacturer in the former Czechoslovakia to treat influenza and the common cold. During this period, clinical trials were conducted for those uses that involved nearly 4,000 patients and volunteers across six randomized, double-blind, placebo-controlled trials. The clinical trials demonstrate that PEA has clear treatment and prophylactic effects in respiratory infections, and is safe in its use, the company said.
FSD Executive Co-Chairman and CEO Raza Bokhari called the FDA approval of concept “a paradigm shift” for the company and that it contacted the FDA in late March after finding out that some Italian physicians and scientists were advocating for the drug’s use in treating COVID-19.
“Numerous studies over the past 40 years also validate the efficacy and safety of ultramicronized PEA in the treatment and prophylactic effects in respiratory infections. These studies also pointed out that the ease of application of PEA offers the possibility to have a quick therapeutic answer ready in case of a flu epidemic.” – Bokhari in a statement
FSD spent $17.5 million to purchase the rights to the drug earlier this year and rebranded it as FSD-201, according to a Philadelphia Inquirer report.
“Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm,” Bokhari said in an interview with the Inquirer. “[FSD-201] is not a virus killer. But we believe it can mitigate that immune response, which can be fatal.”
The firm is currently conducting a Phase 1 clinical trial for the drug in Australia. The FDA approval only allows the company to submit an application for U.S. trials, rather than approval to conduct them. Bokhari indicated they would seek trial approval from the FDA after the results of the Australian study.
Last month, a study published in Preprints suggested that cannabis extractions containing THC and CBD could help prevent the coronavirus from spreading to and infecting humans by lowering the production of two proteins commonly hacked by the novel coronavirus to create a new infection.