The U.S. Health Authorities Could Give the Green Light to the First Cannabis Medicine

The green light has still not been given by the Food and Drugs Administration (FDA), the American regulator for the matter, however the shares of GW Pharmaceutical, the company that produces Epidiolex, a medicine made from cannabidiol, have shot up (by as much as 130%) after the conclusions from a study in a very advanced stage were released.

The enormous importance of this event is due to the fact that, up until now, the medical benefits of cannabis lacked anything close to official backing. In this case, after having obtained the conclusions as part of a research study that follows the guidelines of the FDA, we would be talking “for the first time” about what, according to experts, could be considered as “empirical evidence”. In other words, this is the first clear sign of a cannabis medicine that could very soon receive the approval of the institution.

During the mentioned tests, the patient, a child with an uncommon form of epilepsy known as Dravet syndrome, has reduced his tremors by 40% after receiving treatment with Epidiolex over the course of 14 weeks.

The product does not need to wait for the approval of the FDA in order to go on the market. The British pharmaceutical industry can sell it completely legally provided that it does not talk about it as a medicine or mention its medical properties. Otherwise, a sanction would be imposed. In fact, the American regulating body already sent warnings to several manufacturers last year in order from them to stop advertising in such a way.

If approval comes, which seems very probable, they could promote it just like any other medicine, however it is true that, today, Epidiolex already has the special status of an “orphan medicine”, that is applied to some products that are devised to combat rare illnesses.

The product, as is standard with medicine, does not contain the psychoactive element of cannabis (tetrahydrocannabinol or THC). Rather, it is made from another component of the plant named cannabidiol (CBD), whose medical properties have been extensively studied and described by several researchers.