There is an abundance of cannabidiol (CBD) on the internet, and it is said to have a wide variety of effects, such as enhancing sleep, treating cancer, and reducing anxiety. Epidiolex, on the other hand, is the only CBD-based medicine that has been granted permission by the Federal Drug Administration (FDA) for consumption by humans.
This product is intended to be taken orally and is consistent with syrup. It is made up of a refined version of CBD extracted from cannabis. This medication is the first of its kind to reach the market in the new class of medications used to treat seizures. In addition, it is the only prescription medication that contains CBD that has been approved by the FDA after going through its stringent approval process.
Customers have accurate information regarding the products they purchase.
The only way to acquire it is by obtaining a prescription from a physician who has been through the necessary training and testing to prescribe it for a specific disease. Additionally, CBD must be obtained from a company that abides by stringent manufacturing requirements, also known as good manufacturing practices. This ensures that customers have accurate information regarding the products they purchase. In addition, these regulations aim to ensure that the products do not contain any additional active substances that could potentially cause adverse effects.
At the conference, the panelists listened to the heartfelt testimonies of families whose children are affected by Dravet syndrome and Lennox-Gastaut syndrome, both of which are forms of epilepsy that are both debilitating and resistant to treatment. Because of these experiences, it became clear that there is a need for alternative therapeutic approaches. A Food and Drug Administration (FDA) representative who took part in the discussion stated, “These individuals are patients who have been neglected, and we have the opportunity to provide them with a novel treatment alternative.”
In medical research, this methodology is frequently called the conventional gold standard.
Nevertheless, there is a lack of evidence to support the use of CBD as a potential therapeutic option. On the other hand, most studies rely primarily on anecdotal accounts rather than clinical trials that include a control group. In these trials, some individuals are given a placebo, while others are given the treatment. In medical research, this methodology is frequently called the conventional gold standard. In addition, the number of experiments that have been conducted has been limited, and the results of those experiments have been inconsistent.
Among people who have been diagnosed with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS), a recent study that was published the year before found that cannabidiol (CBD) did not demonstrate any effectiveness that was superior to that of a placebo in reducing the frequency and severity of seizures. This study was conducted on a small scale, and the participants had a wide range of comorbidities, all of which had the potential to impact the results. Despite this, the researchers assert that their findings support the findings of previous studies that have demonstrated that CBD is a viable option for people who suffer from seizures that are resistant to treatment.
Majority of the adverse events being mild or moderate in intensity.
In a similar vein, another study found that people who had been diagnosed with Tuberous Sclerosis Complex (TSC) experienced a reduction in the number of seizures they experienced when they included CBD as part of their regular treatment regimen. During the GWPCARE6 trial, the utilization of supplementary treatment led to a reduction of nearly forty percent in the average number of seizures associated with TSC. This encompassed a variety of seizures, including focal and generalized seizures, absence seizures, myoclonic seizures, and infantile spasm seizures, among others. An additional point is that these enhancements were preserved throughout the three-year follow-up period.
During the randomized and double-blind phase of the GWPCARE6 study, the addition of CBD was well tolerated, with the majority of the adverse events being mild or moderate in intensity. The findings from the open-label extension (OLE) phase of the experiment were included in the safety data presented at the symposium.
Over the course of a twelve-week therapy period known as the Open-Label Extension (OLE), patients who are currently receiving the medication are permitted to continue receiving treatment under the supervision of their physicians, provided that the treatment is deemed safe. Afterward, the researchers will evaluate the effects of the treatment still being administered. They will assess the changes in the frequency of seizures related to TSC, the scores on the Beck Anxiety Inventory, and the quality of life measures.
