Is the U.S. Food and Drug Administration (FDA) changing its stance on medical cannabis? It would seem so since the agency will likely approve Epidiolex, a CBD extract epilepsy drug this summer. If approved, the drug would mark the first cannabis drug made from the plant.
GW Pharmaceuticals, plc (NASDAQ: GWPH) is a British drugmaker; they want to sell the drug in the United States and are seeking FDA approval. The FDA is expected to make a decision this summer, but first, to show caution, they formed a panel of independent experts to look at the effects of the drug on the nervous system. GWPH is also the maker of multiple sclerosis (MS) drug Sativex, the first cannabis-derived drug to receive market approval in any country.
Last week, the panel unanimously recommended that the FDA approve the drug, which helps severe forms of epilepsy. If the FDA does approve it this summer, Epidiolex will be tested on a small group of patients. The FDA has previously approved some synthetic cannabinoid drugs like Marinol but has never approved a naturally-derived drug. The FDA would approve Epidiolex for epilepsy only, but doctors would likely use the drug as “off-label,” prescribing it for other uses.
GW developed Epidiolex for severe epilepsy syndromes like the rare genetic disorder called Dravet syndrome and Lennox-Gastaut syndrome that causes multiple seizures. Epilepsy drugs are important since the Epilepsy Foundation reports that 1 million families with an epileptic member have found nothing to control their seizures. In Thursday’s hearing, Sam Vogelstein, a teenager from California, spoke to the panel. Epidiolex did not pay for him to do so. Vogelstein said that he could experience up to 100 seizures per day, but he has been free of seizures for more than two years because of the drug.
FDA trials would be limited and small. Many experts are concerned because most traditional epileptic drugs have very harsh side effects and terrible drug interactions. The panel said the data collected thus far does not show any evidence of CBD potential for abuse or liver damage.
GWPH CEO Justin Glover said, “We're obviously very pleased by the unanimous recommendation in support of the approval of Epidiolex. It's a very important milestone in the approval process.” GW data from two experimental clinical trials for both Dravet and Lennox-Gastaut syndromes showed a drastic reduction in seizures.
Glover praised the FDA for taking one more step towards “a breakthrough in the field of epilepsy." “Epidiolex is the first in a new class of treatments with a new mechanism of action against epilepsy,” Glover said.
CBD (cannabidiol) is only one of over 80 active cannabinoids found in the plant. The most well known, THC (tetrahydrocannabinol) produces the “high” for which marijuana is known. CBD does not, so lawmakers feel more comfortable that it is less likely to be abused as a drug.
FDA approval would be a sharp turn from the overall stance that the federal government has taken. Attorney General Jeff Sessions has led the charge. Congressmen are starting to waiver as well, and have introduced legislation to deschedule cannabis to a lower than Schedule I drug.