Cannabis-based treatments make a breakthrough after the Food and Drug Administration (FDA) approved the prescription cannabidiol medicine. A drug Epidiolex is a formulation of cannabidiol, otherwise known as CBD, which is used to treat different kinds of epilepsy.
Epidiolex helps patients with Dravet syndrome and Lennox-Gastaut syndrome during the treatment process. FDA’s Dr. Billy Dunn shares that the approved drug to individually treat Dravet and Lennox-Gastaut patients will provide an essential improvement in the approach of treatment and therapy for people with the said conditions.
FDA advisers approved Epidiolex in April. However, the approval only covers the use of the liquid drug for Lennox-Gastaut and Dravet syndrome patients. Epidiolex, based on research, reduce seizures from epilepsy patients. It also helps return some children to near-normal function.
Dravet syndrome, a rare genetic condition, affects infants. The symptoms of the disease will start with fever-related seizures before transitioning into more severe types of seizures — children suffering from Dravet syndrome experience poor development in language and motor skills. They also suffer from behavioral disorders and have difficulty relating to other children.
Lennox-Gastaut syndrome, meanwhile, usually affects children starting at age 3 to 5. Most children with Lennox-Gastaut syndrome suffer from learning problems and intellectual disability. Because of their condition, children need help with daily activities.
In recent studies, medical marijuana has shown benefits in combatting anxiety, counteracting nausea, and may affect symptoms of glaucoma and sclerosis. The substance is legal in 29 U.S. States, Guam, and Puerto Rico.
Along with Epidiolex, the FDA approves other cannabis-based products like the synthetic formulation Marinol, which could treat severe appetite loss and nausea in diseases such as AIDS.
A Step Forward with Precautions
Despite the big step to the approval of cannabis for medical purposes, the FDA remains insistent that the acceptance of Epidiolex is not an approval of marijuana for medical purposes in general. FDA Commissioner Dr. Scott Gottlieb states that cannabis-based drugs being used to treat diseases must be proven safe and effective.
Dr. Gottlieb states that the cannabis-based product is an essential medical advancement. However, Dr. Gottlieb also notes that the FDA approved one specific CBD formulation for a specified use. It is different from pure cannabis.
The FDA warns the public against falsified claims that medical companies are using to sell cannabis-based drugs. Cancer cures, pain relievers, and depression medicines are among the treatments companies use to sell marijuana-based products. The promotion of those unproven products may hinder patients to purchase the appropriate and approved treatment for severe and fatal diseases.
The FDA will review legitimate applications for approval of cannabis-based drugs. However, there needs to be scientific studies and demonstration process to prove that the products in question are safe and effective.
Dr. Gottlieb also adds that new therapies derived from marijuana and its components must acquire a consistent and high quality.
Epidolex, while a formulation of CBD, does not contain the amount of tetrahydrocannabinol, or THC, needed to provide a user in what it values for recreational purposes.
Dr. Gottlieb reveals that the approval of Epidiolex is not a go-signal for other marijuana-based products. Epidiolex is a purified form of CBD. It is given to patients in a reliable dosage through a reproducible delivery route to make sure that the users will anticipate its medical benefits instead of its recreational use.
Despite its precautions and strict regulations, the FDA acknowledges the effects of research and scientific studies in the medical field, especially for CBD. With the further dedication to proving the cannabidiol’s benefits in treatment and therapy, medical marijuana enthusiasts may cover more breakthroughs for the years to come.