In Australia, a pioneering study was conducted on medicinal cannabis, that is, on the use of the prohibited plant for healing purposes. Today, as you know, it is used for many pathologies. This time it was adopted to treat children with epilepsy.
But not just any epilepsy. Those cases of epilepsy resistant to traditional treatments.
And contrary to what parents thought, the cannabis used had something different.
The study showed that the main psychoactive ingredient of cannabis, tetrahydrocannabidiol (THC), and the closely related compound THCA, were present in most of the extracts, but the quantity was generally not sufficient to produce intoxicating effects.
The Food and Drug Administration has approved Epidiolex, tested in three randomized, placebo-controlled clinical trials involving 516 patients with Lennox-Gastaut syndrome or Dravet syndrome.
„CBD – writes the FDA in its note – is the chemical component of the plant commonly known as marijuana that does not cause intoxication or the euphoria that entails tetrahydrocannabidiol (Thc). Thc (and not CBD) – states the note – is the main psychoactive component of marijuana „.
„This approval – said Commissioner Fda Scott Gottlieb – serves as a reminder that the advancement of development programs that correctly evaluate the active ingredients contained in marijuana can lead to important medical therapies. And the FDA is engaged in this type of careful scientific research and drug development. Controlled clinical trials that test the safety and efficacy of a drug, together with careful review through the FDA approval process, are the most appropriate way to bring marijuana-based treatments to patients. Due to the adequate and well-controlled clinical trials that have supported this approval, prescribers may have confidence in the uniform strength of the drug and the consistent administration that supports the appropriate administration necessary for the treatment of patients with these complex and severe epileptic syndromes. We will continue to support rigorous scientific research into the potential medical uses of marijuana products and we will work with product developers interested in offering patients safe, effective and high quality products. But, at the same time, we are ready to take action against illegal marketing of Cbd-containing products with unproven medical claims. The marketing of unapproved products, with uncertain dosages and formulations, can prevent patients from accessing appropriate and recognized therapies for the treatment of diseases.