Growing approval for pharmaceutical CBD by regulatory bodies like Argentina’s National Agency for Medicines, Food, and Medical Technology is significant for patients suffering from neurological disorders such as severe epilepsy as it provides access to reliable, consistent products that are available through pharmacies. However, while progress has been made, there is still a long road ahead.
Argentina’s National Agency for Medicines, Food and Medical Technology (ANMAT) recently approved a Pharmaceutical CBD product, with its stringent quality testing according to the highest pharmaceutical standards, and at an accessible cost. The formulation comes with a specific indication for the treatment of severe forms of epilepsy resistant to other treatments.
To understand why this pharmaceutical CBD approval represents a milestone for the health of patients with neurological conditions in general, it is necessary to briefly review its history. However, before we begin, take a moment to download our free cannabis news app.
The Path to Pharmaceutical CBD
The path of cannabidiol in pharmaceutical CBD is very different from that of most current medicines, which generally arise from basic research with molecules in the laboratory, to go from there to a long process of clinical trials after which they are approved by health authorities. Only at the end of this path can doctors prescribe them and patients recognize their benefits.
Instead, CBD oil began to be used in the last three decades based on some pioneering medical studies, and it was the use itself that provided evidence of its benefits to treat different ailments that could not be cured with standard medications.
The case of the American girl Charlotte Figi, who later died of covid-19 as soon as the pandemic broke out, was especially inspiring: her parents strongly advocated the legalization of the use of cannabis oil to alleviate the serious crises caused by Dravet syndrome, a severe form of epilepsy that did not respond to any other treatment.
Unmet Demand for Certified Pharmaceutical CBD
The demand for pharmaceutical CBD oil has increased throughout the world, in parallel with medical research into its use. The patient communities themselves, at first, began to cultivate the plant, produce it and market it. In a short time, an informal pharmaceutical CBD market emerged to cover these unsatisfied needs, but with great heterogeneity (between different oils and between different batches of the same oil) and without analytical studies to ensure quality and safety.
In Argentina, production in informal circuits coexisted with the importation of dietary supplements and other medicinal products based on CBD with prohibitive costs, until the US health agency approved, three years ago, the first pharmaceutical CBD.
“In cases of refractory epilepsies, prescription and acquisition became a very cumbersome procedure, with affidavit forms and exception declarations, because it involved acquiring a very high-cost drug that did not exist in the country,” explains Dr. Claudio Waisburg, pediatric neurologist (MN 98128) and director of the Soma Institute.
On the other hand, the specialist points out, “the medical indications for cannabidiol go far beyond refractory cases of epilepsy, which were the only ones for which it could be accessed through this procedure.”
A Radical Change
The pharmaceutical CBD recently approved by ANMAT, Kanbis®, from the Elea laboratory, has highly purified cannabidiol (99%). It differs from ordinary cannabis oils due to its defined, declared and verifiable quantitative composition, with a stable pharmaceutical form that guarantees efficacy and safety according to the clinical trials carried out, as well as batch-to-batch quality and consistency.
For pharmaceutical CBD approval, ANMAT used the same reference criteria used by the FDA in 2018 and by the European Medicines Agency (EMA) in 2019, from which the production of medicinal cannabis definitively acquires a new standard, characterized by production in industrial plants under Good Manufacturing Practices (GMP) standards, with supervision and analysis by highly qualified experts and with agricultural production and harvesting methodology that ensures the reproducibility of the chemical composition of the raw material.
The affordable cost of this locally manufactured pharmaceutical CBD, which will be distributed in pharmacies throughout the country, constitutes another great factor of change: “The sale in pharmacies and the significantly cheaper price represents a great benefit for consumers. patients,” says Dr. Waisburg. And he also opens up, for specialists, the possibility of prescribing pharmaceutical CBD to treat other neurological ailments, from chronic pain to Parkinson’s disease, for which cost and lack of accessibility have been an impediment until now.
The Beginning of a Long Road
Up to 2% of the population may suffer from an epileptic disorder, and a quarter of them, refractory forms, resistant to any treatment. Pharmaceutical CBD is now authorized in Argentina basically to treat two of them (Lennox-Gastaut syndrome and Dravet syndrome) and the US FDA recently also approved it for tuberous sclerosis complex. However, the therapeutic benefits of cannabis derivatives are far from being exhausted there.
For Dr. Alejandro Andersson, neurologist (MN 65836) director of the Buenos Aires Institute of Neurology (Inba), having an accessible and quality version of pharmaceutical CBD “is very positive for patients.”
For this specialist “it is undoubtedly the beginning of another long road, because there are more than 120 active components derived from cannabis, each one with its specific pharmacological effects, described in more than 10 thousand scientific studies”.
“There are many more applications than those indicated by the ANMAT seal of approval, and many more will be developed in the near future,” said Dr. Andersson.
Pharmaceutical CBD Assures Safety and Quality of Life
“According to published studies and according to my clinical experience in Canada, the applications with the best results include the use of pharmaceutical CBD with pain and associated pathologies: fibromyalgia, rheumatic, oncological conditions and others,” says Dr. Waisburg, who also mentions, among the possible indications, developmental disorders (PDD), autism spectrum disorders or sleep disorders. “It can also be prescribed for people with Parkinson’s disease and dystonia, as long as we understand that, as happens with epilepsy, there is no cure for any of these diseases, although notable improvements in quality of life can be achieved.”
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First published by El Litoral, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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