In a major regulatory win for the entire cannabis industry, the stringent Brazilian Health Regulatory Agency (Anvisa) has approved a cannabis-derived CBD 50 mg/ml product produced by Verdemed Pharmaceuticals, in partnership with Colombian-American operator Clever Leaves Holdings Inc CLVR.
In addition to being able to commercialize the product, Verdemed will provide the medicine for a new clinical study on medicinal cannabis uses for long-haul COVID-19 led by InCor, the Heart Institute of the São Paulo University Medical School (FMUSP).
“Now, doctors and patients can grow even more confident. That also improves the results’ credibility,” said the study coordinator, Professor Edimar Bocchi, director of the Heart Failure and Mechanical Devices for Cardiac Insufficiency Nucleus at the Heart Institute (InCor) of the São Paulo University Medical School.
Verdemed and Clever Leaves are in the final phase of attaining the Sanitary Authorization from Anvisa to produce CBD 25mg/ml as well.
CBD For Long-Haul COVID-19
“We’re waiting on the green light to get the clinical trial underway this very month of November since COVID-related issues bear urgency,” explained Verdemed’s CEO José Bacellar.
This will be the first Brazilian triphasic trial on the effects of CBD on the treatment of long-haul COVID-19, defined as the persistence of side effects for over 60 days after the start of the infection. Fatigue, muscle weakness, headaches, psychiatric issues, vomiting and diarrhea are some discomforts expressed by the patients.
This is the second time InCor and Verdemed have partnered up. The organizations recently initiated a study on the uses of CBD in treating cardiac insufficiency, a chronic and severe disease and the main cause of cardiovascular deaths in Brazil, making up 27% of national deaths.
Approved in July by USP’s Research and Education Committee, the trial will use the 100 mg/ml CBD produced by Verdemed in the USA.
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