Reading: 7 minutesIn 2019, the Brazilian Health Surveillance Agency (Anvisa) approved the commercialization of Cannabis-based products in Brazilian pharmacies and drugstores, through Resolution 327/2019. This was an important step in the search for the consolidation of treatments based on the plant in Brazil. Today, there are already 14 medical cannabis products registered by Anvisa. The most recent were approved in February 2022.
In this content, we will list the products that have already been registered and we will talk about the difference between cannabidiol (CBD) and Cannabis sativa extract,Read on and check out also what the studies say about the main phytocannabinoids (other than CBD).
Medical Cannabis and Anvisa: list of products released
Of the 14 products registered by Anvisa, five are based on extracts of Cannabis sativa and nine consist only of cannabidiol (CBD). We will talk more about this differentiation in the next topic.
It is also worth remembering that the dispensing of Medical Cannabis should be made by a registered pharmacist, from the due medical prescription in a B-type special prescription form (blue color), if the product contains less than 0.2% of THC and in a A-type special prescription form (yellow color), if the product contains more than 0.2% of this phytocannabinoid. Below is the list of products with the health authorization for commercialization in Brazilian pharmacies and drugstores, so far:
- Canabidiol Prati-Donaduzzi (20 mg/mL; 50 mg/mL e 200 mg/mL);
- Canabidiol NuNature (17.18 mg/mL);
- Canabidiol NuNature (34.36 mg/mL);
- Canabidiol Farmanguinhos (200 mg/mL);
- Canabidiol Verdemed (50 mg/mL);
- Canabidiol Verdemed (23,75 mg/mL);
- Canabidiol Belcher (150 mg/mL);
- Canabidiol Aura Pharma (50 mg/mL);
- Canabidiol Greencare (23,75 mg/mL).
- Cannabis sativa extract Promediol (200 mg/mL);
- Cannabis sativa extract Zion Medpharma (200 mg/mL);
- Cannabis sativa extract Alafiamed (200 mg/mL);
- Cannabis sativa extract Greencare (79.14 mg/mL);
- Cannabis sativa extract Ease Labs (79.14 mg/mL);
Differences between CBD and Cannabis extract
Products registered only with the name“Cannabidiol (CBD)” are isolated products, i.e., they contain only the phytocannabinoid Cannabidiol in their formulation, so they are also called phytodrugs. The products registered under the name“Cannabis sativa extract” bring in their composition a set of several substances extracted from the plant, including several phytocannabinoids besides CBD, and other important elements of the plant such as terpenes and flavanoids.For this reason, products derived from Cannabis sativa extract are also called phytotherapeutic medicines.
Learn more about the rationale for the use of phytotherapeutic medicines in our post about the entourage effect:
Entourage effect: why the whole plant is better than its isolated parts
Cannabidiol
It is a common expression used in the industry to address to an isolated compound is in its purest form. In the case of CBD isolate,its extraction involves careful processing to remove all other elements of the Cannabis plant, such as other cannabinoids. delta-9-THC (Tetrahydrocannabinol), CBG (Cannabigerol), CBC (Cannabichromene), CBDA (Cannabidiolic Acid), and other substances such as terpenes and flavonoids.
Although the option for CBD isolate may seem advantageous in terms of safety profile – due to the absence of THC – in these formulations the so-called Entourage Effect,or entourage effect of the plant. This phenomenon is characterized by the synergistic action of the set of substances in Cannabis, which can potentiate its therapeutic effects and reduce possible side effects, including the CBD,.
Cannabis sativa Extract
The Cannabis sativa extract,in turn, is obtained from the whole plant extract, i.e., there are in its composition a number of substances in addition to the CBD, such as other cannabinoids, esters, terpenes, and flavonoids.
So far, five full-spectrum products have been registered with ANVISA, i.e., whole derivatives of the plant. They are:
- Cannabis sativa extract Promediol (200 mg/mL);
- Cannabis sativa extract Zion Medpharma (200 mg/mL);
- Cannabis sativa extract Alafiamed (200 mg/mL);
- Cannabis sativa extract Greencare (79.14 mg/mL);
- Cannabis sativa extract Ease Labs (79.14 mg/mL);
It is important for you to know that since 2017, ANVISA has registered as a medicine, a whole extract of the plant called Mevatyl, registered in several other countries under the name Sativex®. Manufactured by GW Pharmaceuticals and launched in 2005 in Canada, Sativex® was the first Cannabis-based drug approved in several regulatory agencies in the world. The drug contains similar proportions of tetrahydrocannabinol (THC) and cannabidiol (CBD) and has been registered to treat pain symptoms associated with muscle stiffness and spasticity in multiple sclerosis.
What studies say about other cannabinoids
Let’s now explore what we already know scientifically about phytocannabinoids other than the cannabidiol.
THC
The tetra-hydrocannabinol (THC) is the component of Cannabis known for its psychotropic properties. However, in a medical use context, the risk of psychotoxic reactions from THC is rare.Even when well exploited, the psychoactivity of this phytocannabinoid can provide differentiated therapeutic properties in chronic pain clinical conditions, mainly neuropathic pain, common symptoms in cancer patients and in palliative care, such as nausea, vomiting, inappetence, fatigue and apathy.
As for cancer patients, it has been known for decades that THC can be a valuable adjuvant in radio and chemotherapy regimens, due to its antiemetic potential, as demonstrated in this research This is a randomized, controlled, double-blind study from the 1970s. In addition, this cannabinoid is capable of stimulating the appetite, reducing pain conditions and anxiety and significantly improve sleep pattern, fundamental aspects in this clinical context.
>>You can read the full research here: Antiemetic effect of delta-9-tetrahydrocannabinol in patients receiving cancer chemotherapy..
THC is also scientifically proven to have antispasmodic and muscle relaxing effects. As we have previously discussed, the first formulation of Cannabis extract registered with several regulatory agencies in the world, Sativex®was approved for the treatment of pain associated with the spasticity of Multiple Sclerosis.
CBG
The Cannabigerol (CBG) is a cannabinoid that is gaining attention in the scientific community due to its anti-inflammatory properties and possible antineoplastic properties. One example is this research which correlated the use of CBG to reduced progression of glioblastoma cells, the most aggressive primary brain cancer.
>>You can read the full research here: Cannabigerol Is a Potential Therapeutic Agent in a Novel Combined Therapy for Glioblastoma..
CBDA
The cannabidiolic acid (CBDA) is the acid form of CBD. Among its therapeutic properties is its potential to inhibit vomiting and anticipatory nausea – a condition for which there are as yet no established therapies. Compared to the CBD, CBDA has been shown to be more effective in the management of this condition, as pointed out in this pre-clinical study..
>> You can read the full study here: Cannabidiolic acid prevents vomiting in Suncus murinus and nausea-induced behavior in rats by enhancing 5-HT1A receptor activation..
CBC
The cannabichromene (CBC) is also a promising target in scientific research. It is believed that this cannabinoid has the potential to increase levels of the body’s natural endocannabinoids, such as anandamide,which is associated with feelings of well-being and happiness.
The more Science advances in the studies of Endocannabinoid Medicine, the more the medical community feels confident to incorporate this vast therapeutic arsenal into its prescriptive practices.
Anvisa recent resolutions also foster this scenario, making physicians more confident in prescribing Medical Cannabis and facilitating the access to safe and qualified medical Cannabis products.
We emphasize, however, that a specialized education in the field is crucial to achieve the technical knowledge necessary to make assertive prescriptions, in order to potentiate the therapeutic effects of these products and modulate possible adverse effects.
The WeCann Academy is committed to your learning journey through the International Certification in Endocannabinoid Medicine. We provide this disruptive knowledge to physicians who wish to be prepared for the Medicine of the future.
We connect experts from around the world in a global community of Endocannabinoid System research and studies to link scientific knowledge and practical experience in the medical use of Cannabis.
Do you want to join our community? Contact us and get ready for this new frontier of Medicine!
References
Bolognini D, Rock EM, Cluny NL, et al. Cannabidiolic acid prevents vomiting in Suncus murinus and nausea-induced behavior in rats by enhancing 5-HT1A receptor activation.. Br J Pharmacol. 2013.
Lah TT, Novak M, Pena Almidon MA, Marinelli O, Žvar Baškovič B, Majc B, Mlinar M, Bošnjak R, Breznik B, Zomer R, Nabissi M. Cannabigerol Is a Potential Therapeutic Agent in a Novel Combined Therapy for Glioblastoma.. Cells. 2021.
Sallan SE, Zinberg NE, Frei E 3rd. Antiemetic effect of delta-9-tetrahydrocannabinol in patients receiving cancer chemotherapy.. N Engl J Med. 1975.
