First CBD (Cannabidiol) based drug for epilepsy patients in Colombia

  • For the first time in Colombia, a pharmaceutical-grade CBD (Cannabidiol) based drug is used for a specific therapeutic indication
  • The product was developed and is produced at the PROCAPS plant in Barranquilla, which is the only plant in Latin America with an FDA certificate (US Food & Drug Administration).
  • The pharmaceutical-grade CBD-based product is not psychoactive in patients and produces an anticonvulsant effect in patients with 2 years of age and older.
For the first time in Colombia, patients with refractory epilepsy will be able to receive treatment with cannabis-based medicine. This new drug is the first and only INVIMA approved pharmaceutical grade Cannabidiol with scientific support.
According to the World Health Organization, approximately 65 million people suffer from epilepsy worldwide, which makes it the most frequent chronic neurological disorder. Of this number, it is estimated that 70% of people with epilepsy could live without seizures if properly diagnosed and treated, and it has been considered that 80% of patients live in low- and middle-income countries.
Epilepsy is a chronic brain disease that leads to the development of recurrent seizures. These epileptic seizures are caused by abnormal electric shocks that can cause alterations in the movement, behavior, consciousness, and sensations of people. According to the World Health Organization (WHO), there are 650,000 people in Colombia, 1.3% of the population, of whom 30% have refractory epilepsy.
Although current treatments for diagnosed patients can control seizures in approximately 80% of cases, the remaining 20% ​​[1] of patients with epilepsy have seizures that cannot be adequately controlled by the currently available means.
After recognizing this panorama, the Colombian pharmaceutical company PROCAPS developed a CBD (Cannabidiol) based medicine for the treatment of refractory epilepsy in patients with Dravet Syndrome and Lennox Gastaut Syndrome.
CBD (Cannabidiol) is a cannabinoid derivative of the cannabis plant, found in varying proportions depending on the strain. Although habitually the common people usually associate cannabis with addiction, this component is not psychoactive and its use is intended for therapeutic purposes thanks to its multiplicity of benefits as an anticonvulsant, anti-inflammatory, anxiolytic, antioxidant, among others.
The CBD of this innovative product has an anticonvulsant effect, reduces seizures in patients 2 years of age and older, and most importantly, does not produce a psychoactive effect in patients. It should be noted that currently the use of CBD in standardized and controlled formulations, for treatments of refractory or drug-resistant epilepsy in children and young people, has guaranteed an anticonvulsant effect of up to 50% [2].
“Patients and their families need alternative treatments that control crises and have fewer side effects. Treatment of epilepsy based on CBD (Cannabidiol), presents improvements in crisis control in children with severe epilepsy. In countries like the United States, the FDA has already approved Cannabidiol-based oral solution medications for the treatment of epilepsy” said Dr. Orlando Carreño, a neuro pediatrician-epileptologist, member of the Colombian Association of Child Neurology.
CBD (Cannabidiol) should not be confused with THC or Tetrahydrocannabinol because even though they are both components of the cannabis plant, their effects are completely different. THC is the one that produces psychoactive effects such as altered perception and modification of mood; while CBD does not have psychoactive.
Taking into account that people suffering from epilepsy tend to present more physical problems such as fractures and bruises derived from episodes of involuntary movements, as well as higher rates of psychosocial disorders such as anxiety and depression, the drug was developed to add up to the effect of lowering the number of drugs in patients and not to compete with other anticonvulsant drugs.
It is worth mentioning that it is the first time in Colombia that a CBD-based drug (Cannabidiol) is used for a specific therapeutic indication (epilepsy), for this reason, PROCAPS has provided its infrastructure, knowledge, and experience in favor of this innovation.
 “PROCAPS has more than 40 years of experience and since its beginning has focused its efforts on developing innovative medicines and services that meet the highest international standards, offering differentiated solutions that contribute to improving the health of the communities with which we interact. With the launch of this new medicine, we want to tell Colombia and the world that the cannabis industry can be used to help the well-being and quality of life of people suffering from different diseases, ”said Yan Guzman, Director of the Pharma Division of PROCAPS.
PROCAPS has arranged its manufacturing capabilities in Colombia and its human team for the development and production of this new product. The PROCAPS plant in Barranquilla is certified to export innovative pharmaceutical solutions and has the FDA certificate for some of its exportation products — the only plant in Latin America that has this distinction—.
[1] http://www.anmat.gov.ar/ets/Cannabinoides_y_epilepsia.pdf
[2] https://www.fundacion-canna.es/cannabis-y-el-tratamiento-de-la-epilepsia

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