There is an abundance of information available on the internet about cannabidiol (CBD), and it is claimed to have many benefits, such as improving sleep, treating cancer, and reducing anxiety. Nevertheless, the Federal Drug Administration (FDA) has exclusively authorized the consumption of Epidiolex, a pharmaceutical derived from CBD, for human use.
Furthermore, this product is formulated as an oral medication with a syrup-like consistency, and it contains a concentrated form of CBD derived from cannabis. Furthermore, the sole CBD drug has obtained FDA approval following a thorough and stringent review process. This medicine belongs to a novel class of anti-seizure treatments.
Testimonies emphasized the urgent necessity for a more excellent range of therapeutic alternatives.
Only licensed healthcare practitioners who have completed the necessary training and examinations can provide patients with a prescription for a specific ailment. Furthermore, the CBD must originate from a company that strictly follows rigorous manufacturing standards, also known as good manufacturing practices. This guarantees that clients have a clear understanding of the precise nature of their purchase. Furthermore, these requirements ensure that the objects are free from any additional active components that may have negative implications due to their existence.
At the meeting, the panelists heard sincere stories from families with children suffering from Dravet syndrome and Lennox-Gastaut syndrome, two severe forms of epilepsy that are unresponsive to therapy. These testimonies emphasized the urgent necessity for a more excellent range of therapeutic alternatives. “These patients have been neglected, and we have the chance to provide them with a novel treatment alternative,” stated a Food and Drug Administration representative during the discussion.
The study had a narrow focus, and the participants had diverse comorbidities
However, there is a lack of research supporting the efficacy of CBD as a therapy. Most studies depend on anecdotal accounts rather than clinical trials, which are widely recognized as the most reliable medical research. These trials consist of a control group where specific individuals are given a placebo while others are given natural medicine. Furthermore, the results of the limited number of studies have displayed a lack of consistency.
Based on the results of a study published last year, CBD did not demonstrate superior efficacy compared to a placebo in reducing seizures in patients with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). The study had a narrow focus, and the participants had diverse comorbidities that may have impacted the results. In contrast, the researchers affirm that these findings lend support to previous studies that have demonstrated the promise of CBD as a therapy alternative for individuals with treatment-resistant seizures.
Patients with TSC who supplemented their existing medication with CBD reported a decrease in the frequency of their seizures.
Similarly, another study found that patients with TSC who supplemented their existing medication with CBD reported a decrease in the frequency of their seizures. The GWPCARE6 trial found that the additional medicine led to an average reduction of about forty percent in the frequency of seizures related to TSC. The seizures encompassed both focal and generalized seizures, including absence, myoclonic, and infantile spasm seizures. Moreover, these enhancements were sustained throughout the three-year follow-up period.
In the randomized and double-blind phase of the GWPCARE6 research, CBD was well tolerated, with most side effects mild to moderate. The safety data presented at the meeting included the results of the investigation’s open-label extension (OLE) phase.
The OLE, or Open-Label Extension, is a twelve-week therapeutic timeframe. It allows persons who are currently on medication to get ongoing therapy as long as their physicians consider it safe. Upon continuing the treatment, the researchers will evaluate its outcomes. The researchers will assess the variation in seizure frequency related to TSC, the scores on the Beck Anxiety Inventory, and measures of quality of life.
