Marijuana Weed Delivery Woodland Hills— Today, the Food and Drug Administration of the United States granted approval for the use of Epidiolex (cannabidiol) [CBD] oral solution in the treatment of seizures in patients with the rare and severe forms of epilepsy known as Lennox-Gastaut syndrome and Dravet syndrome. Patients must be at least two years old to be eligible for the treatment. This medication is the first one of its kind to receive approval from the FDA, and it comprises a drug ingredient that is extracted from marijuana and then purified. Additionally, this is the first time the FDA has given its blessing to a medicine intended to treat patients diagnosed with Dravet syndrome.
Cannabidiol, often known as CBD, is a chemical compound that is found in the Cannabis sativa plant, which is more popularly referred to as marijuana. CBD, on the other hand, does not produce the feeling of intoxication or euphoria (often known as the “high”) that tetrahydrocannabinol does (THC).
THC, not CBD, is what gives marijuana its psychoactive effects; it is this compound that is primarily responsible.
“This approval serves as a reminder that pursuing good development programs that appropriately examine active components found in marijuana can lead to valuable medical therapeutics,” the FDA said in a statement after the drug was given the go-ahead to be sold. In addition, according to FDA Commissioner Scott Gottlieb, M.D., “the FDA is dedicated to the kind of meticulous scientific study and drug development that you describe.” “The most suitable way to deliver marijuana-derived therapies to patients is to conduct controlled clinical trials testing the safety and efficacy of a therapy, in addition to thorough scrutiny through the FDA’s drug approval procedure. Prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing that is required for treating patients with these complex and serious epilepsy syndromes thanks to the adequate and well-controlled clinical studies that supported this approval.
These studies were the basis for this approval. We will keep supporting rigorous scientific study on the potential medical uses of goods derived from marijuana, and we will continue to collaborate with product developers that are interested in giving patients products that are safe, effective, and of high quality. But at the same time, we are ready to take action in the event that we come across the unlawful marketing of CBD containing products that make major medical claims that have not been validated. Patients may be prevented from receiving suitable, recognized medications to address serious conditions, which may even be deadly, if unapproved products with unknown dosages and compositions are sold in the market.
The efficacy of Epidiolex was investigated in three clinical trials that were randomized, double-blind, and controlled with a placebo. These trials included a total of 516 patients who were diagnosed with either Lennox-Gastaut syndrome or Dravet syndrome. When compared with a placebo, taking Epidiolex in conjunction with other drugs was proven to be helpful in reducing the number of seizures experienced by the patient.
In the clinical trials, the patients who were given Epidiolex experienced the following side effects more frequently than any others: sleepiness, sedation, and lethargy; increased liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise, and weakness; insomnia, sleep disorder, and poor quality sleep; infections.
Epidiolex must be provided to patients along with a patient Medication Guide that contains essential information about the potential benefits and adverse effects of the medicine. Feelings of agitation, new or worsening depression, hostility, and panic attacks are some of the most dangerous side effects that can occur when taking any prescription prescribed for the treatment of epilepsy. This is also true of all of the drugs used to treat epilepsy. Epidiolex was also found to induce liver damage, although it was considered to be quite minor. However, the drug did raise the chance of uncommon but more severe liver damage. An injury to the liver that is more severe might result in symptoms such as nausea, vomiting, abdominal discomfort, exhaustion, anorexia, jaundice, and/or dark urine. Local Weed Delivery USA only promotes responsible and safe usage. Stay informed and updated, get in touch with us today.