Stock for the British biopharmaceutical company GW Pharmaceuticals jumped over 120% Monday after a successful final phase trial for a drug that treats severe epilepsy in children.
The drug, called Epidiolex, reduced the frequency of seizures by 39% in children with a severe form of epilepsy known as Dravet syndrome who took the drug on top of their existing drug regime over a treatment period of 14 weeks. That compared with a 13% reduction in those who took a placebo on top of their existing drug combination.
The results for Epidiolex were highly anticipated, as it is the first of four “Phase III” trials meant to show the efficacy of the drug for treating epilepsy.
The cannabis-derived drug for children with severe epilepsy significantly reduced the number of seizures they suffered, paving the way for the first-ever U.S. approval of a drug of its kind.
Shares in the company climbed more than 130% after the news. The early success of the first trial bodes well for the other three trials in cue.
GW Pharmaceuticals is also the creator of the cannabis-based multiple sclerosis (MS) drug Sativex. The drug has been approved in 20 other countries for the treatment of MS, and is also being studied for its potential benefits for brain cancer patients. Sativex is still awaiting approval from the FDA for severe pain treatment for cancer patients only when pain can’t be relieved with strong opioids.
Unlike Sativex, GW Pharmaceuticals created Epidiolex with the American pharmaceutical industry in mind. The hope is that the success of compassionate use trials for American children will speed up the regulatory process for Epidiolex in the US.
Because cannabis is still federally illegal, drugs like Sativex and Epidiolex are not being developed in the United States.
“Of all the controlled substances that the federal government regulates, cannabis is treated in unique ways that impede research," Brookings, a leading policy think tank said.
"Specifically, the U.S. government has held back the medical community's ability to conduct the type of research that the scientific community considers the experimental gold standard in guiding medical practice.”
In other words, even though it looks like Epidiolex may be a breakthrough drug with multiple potential uses, the United States will continue to put off serious research into cannabis because of “statutory, regulatory, bureaucratic, and cultural barriers [that] have paralyzed science and threatened the integrity of research freedom in this area.”
The stock market is supporting this cannabis breakthrough, multiple foreign governments have supported GW Pharmaceuticals products, and leading scientists and researchers have pushed for marijuana declassification for years.
How many breakthroughs must happen before America gets onboard? What is the point of having world-class research institutions if outdated dogma keeps them from investigating one of the most potent plants in the world?
We’ve approved opiates, we’ve approved alcohol, and none with as much substantial research as what is available to support medical cannabis.
GW said it planned to use the data to file for approval of the drug with the U.S. Food and Drug Administration, which has already granted the drug certain priority designations to accelerate its approval. If approved, it would be the first cannabis-based medicine to receive the green light from the FDA.
The success of Epidiolex is yet another hard-to-ignore example of why cannabis must be freed from its Schedule I classification.