Starting this month, patients from all over Brazil will be able to have access to the first complete extract of Cannabis sativa for medicinal purposes manufactured in Brazil. The product, popularly known as “full spectrum” or “phytocomplex”, is composed of both cannabidiol (CBD ) as for tetrahydrocarbinol (THC ), as well as other cannabinoids such as cannabigerol (CBG) and cannabinol (CBN).
Medicinal cannabis is a product obtained by extracting cannabinoids, substances present in Cannabis sativa, which act in various parts of the body, including the brain. In addition to full spectrum, there are two other types of medicinal cannabis-based products: CBD isolate (which only has cannabidiol in its composition) and the broad spectrum (which has other cannabinoids except THC).
In Brazilian pharmacies, CBD isolate and full spectrum are already available, but this is the first time that a medicine with the complete extract is manufactured in Brazil . The drug, produced by Ease Labs, can be used to treat fibromyalgia, symptoms related to dementia such as Alzheimer’s and Parkinson’s, as well as chronic pain. The extract contains 25 mg/mL of CBD and less than 0.2% of THC and has been approved by the National Health Surveillance Agency (Anvisa).
“We are proud to introduce the first product of this category manufactured locally and approved by Anvisa, offering an affordable and high-quality alternative to thousands of people,” says Gustavo Palhares, CEO and co-founder of Ease Labs. This is the pharmaceutical company’s second product produced in Brazil. The first was CBD isolate, also available in national drugstores and provided free of charge by the public health system in São Paulo.
CBD and THC: what are the differences and health benefits?
Cannabis is a plant native to central and southern Asia and is popularly known as marijuana. There are three species of the cannabis genus: sativa, indica and ruderalis, the first two being the most studied and well-known. In total, around 120 cannabinoids have been identified in Cannabis sativa, but the most widely studied are CBD and THC.
- CBD : it is responsible for the relaxing effect and, therefore, it is widely used in medicine and pharmaceuticals as an analgesic, sedative and anticonvulsant;
- THC : it is associated with the “euphoric” effect of cannabis and can also be used therapeutically, as an antidepressant, appetite stimulant and anticonvulsant.
“The main difference between them is the euphoric effect: THC is known for the euphoric effect resulting from recreational use of cannabis, while CBD does not have a euphoric effect,” explains Juliana Bogado, a doctor specializing in cannabinoids and academic coordinator at EndoPure Academy, an education platform for health professionals, in an article previously published in CNN .
“In addition, CBD has an anxiolytic characteristic, while THC is anxiogenic; CBD can inhibit appetite, and can be used in the treatment of obesity, while THC has the effect of increasing appetite, and can be used in patients with disorders such as anorexia”, he adds.
In Brazil, the import of cannabis-derived products for therapeutic purposes was approved in 2015 by Anvisa. In the same year, the agency removed THC from the list of prohibited substances. In 2019, the agency regulated the sale of cannabis-derived products in pharmacies, based on a prescription filled out and signed by a doctor.
In 2020, the United Nations (UN) recognized the therapeutic properties of cannabis and removed it from the list of dangerous substances. Several clinical studies attest to the plant’s effectiveness in treating diseases such as multiple sclerosis, epilepsy, Parkinson’s, schizophrenia, Alzheimer’s and chronic pain.
In 2023, medicines based on the plant began to be distributed free of charge by the Unified Health System (SUS) in the state of São Paulo. Another 24 federative units have laws in force or in progress to guarantee the supply of the compound by the SUS.
National production can make the medicine more accessible
National production of complete medicinal cannabis extract makes the product cheaper and more accessible for patients who need treatment, in Palhares’ view.
“The fact that these pharmaceutical processes are carried out locally, in addition to reducing the cost of the medicine, strengthens the supply chain and gives you a structure that allows for sales growth and supports widespread distribution,” says the businessman. “So, we saw that it is essential to operate in this national model and decided to bring our manufacturing here to Brazil,” he adds.
To this end, Ease Labs carries out all processes permitted by Anvisa to be carried out in Brazil, such as purification and standardization of the input and formulation of the final product. Processes that are not permitted in Brazil, such as cultivation, are carried out by a company belonging to Ease Labs, located in Colombia, called Semeya.
“This process means that we have a lower cost than products manufactured in the United States or Europe. By bringing the manufacturing processes to Brazil, even without local cultivation, the production cost is reduced and it is possible to impact more people,” says Palhares.
According to a press release, the pharmaceutical company began distributing its CBD products in 2023 at DrogaRaia and is currently present in the main pharmacy chains in the country, such as Drogarias Pacheco, Drogaria São Paulo, Drogasil, Panvel, Pague Menos, Araújo, Indiana, ExtraFarma and São João.
In addition to the private network, Ease Labs is the supplier of CBD distributed by the public network in the State of São Paulo, after a bidding process. The “full spectrum” extract is only available in the private network, so far.
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Source: CNN Brasil
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