On Monday, March 14, GW Pharma announced that its cannabis drug, Epidiolex, has proved successful in a late-stage trial. The drug has reduced substantially the number of seizures in patients with the Dravet syndrome, a difficult-to-treat form of pediatric epilepsy.
According to Bloomberg, before the company's announcement made on Monday, GW Pharma was down more than 40 percent for the year. On the news of its successful late-stage trial on the drug Epidiolex, the shares of GW Pharma jumped 120 percent. The company is now the Nasdaq Biotech Index's second-best performer this year.
Success with Epidiolex brings new evidence that cannabis-based drugs can be effective beyond typical medical marijuana treatments. The debate about medical marijuana is frequently politicized and well-known. Less known are the efforts of the pharma industry to create narrowly targeted marijuana-based drugs.
Up to date, studies performed by the medical community and the pharma industry have suggested that cannabis derivatives could treat a wide range of medical conditions, from schizophrenia to diabetes. However, the progress in this field has been slow until now.
GW Pharma already has a cannabis-based drug called Sativex, which is approved for use outside the United States. The company partners with pharma giants such as Otsuka and Bayer in developing and selling Sativex. However, sales of GW Pharma's first approved cannabis-based medicine have been disappointing.
A cannabis-based drug to treat seizures from epilepsy that would be approved in the United States would be a far bigger deal than Sativex. According to The Wall Street Journal, the new cannabis drug Epidiolex is made of plant-derived liquid cannabidiol (CBD) present in marijuana. CBD includes no THC and isn't psychoactive.
GW Pharma will test the drug later this year in a second study in Dravet medical condition and in a second rare seizure disorder. Depending on how that second study and trial would go, the company will decide when to file for FDA approval.
The drug will win "orphan" drug status from the FDA in case that will be approved for use in either of those rare disorders. This special status would give the cannabis drug Epidiolex extra years of market exclusivity and GW Pharma would likely sell it at a premium price.
