After years of anecdotal stories from parents who used a marijuana derivative to control their children's seizures, a version of the drug will soon be available as a prescription.
On Monday, the US Food and Drug Administration (FDA) announced the approval of the first cannabidiol (CBD) drug, one of dozens of compounds found in the marijuana plant.
Unlike tetrahydrocannabinol (THC), CBD does not create the "high," which is typically associated with cannabis.
The drug, Epidiolex, is an oral solution for treating two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in people 2 years of age or older.
The drug is also currently the only approved drug for the treatment of Dravet's Syndrome, a rare genetic disease in which infants regularly experience epileptic seizures that may affect their development.
Lennox-Gastaut is estimated to be responsible for 1
Epidiolex was approved after testing efficacy in 516 patients with either Lennox-Gastaut or Dravet syndrome
In three randomized, In double-blind, placebo-controlled clinical trials, the drug, when taken with other medicines, showed the frequency of seizures compared to placebo, according to FDA officials.
"This product approval shows that promoting sound scientific research into marijuana-derived ingredients can lead to an importation of therapies," said Drs. Scott Gottlieb, FDA representative, in a statement earlier this week. "This new treatment offers new opportunities for patients."
Epidiolex is expected to cost as much as $ 5,000 a month, according to The New York Times.
While more than 30 states either decriminalize or have laws in the legalization of marijuana, the federal government remains strict in its policy of rigorously classifying the investment under the Controlled Substances Act (CSA).
The Drug Enforcement Agency (DEA) continues to class marijuana as a Tier 1 drug that has "no current accepted medical use and high potential for abuse." Other drugs on this list include heroin and LSD.
The federal government has 90 days from the date of approval to determine the planning of Epidiolex, which would affect the sentencing guidelines for people who own it without a prescription
This includes researchers who are closer to the potential of CBD want to look at. The FDA said in its announcement that it "will be ready to take action if we see the illegal marketing of CBD-containing products with serious, unproven medical claims."
Paul Armentano, Deputy Director of the National Organization for the Reform of Marijuana Laws (NORML) said he expects Epidiolex to be the first of many possible FDA-approved drugs based on the cannabis plant.
"However, these alternatives should not be regulated as options for replacing the use and regulation of cannabis weed – a product that humans have used safely and effectively as medicine for thousands of years and are now legally recognized in 30 states," he said in a statement.
No change expected
However, Epidiolex is not the first marijuana-based drug approved by the FDA. A THC derivative, most commonly prescribed under the brand name Marinol, was approved by the FDA in 1985. It is used to combat nausea associated with cancer treatment and to strengthen the appetite of AIDS patients.
Dr. Jordan Tishler, a Harvard-trained physician and president and CEO of the Association of Cannabis Specialists, said Marinol's approval does not change the federal government's marijuana perception in the 1980s and does not expect Epidiolex to be a game changer.
"The federal government's position on cannabis is based on a fiction invented at the time of the CSA's ruling (1971)." They deliberately ignored all scientific data since then, "said Tishler Healthline. "I think the federal government will change its position on cannabis in the next few years, but not on this product or on the FDA itself."
Todd Davis, CEO of the company Endexx Corporation, which develops and distributes CBD product lines for pets and people, says Epidiolex approval shows that marijuana has proven medicinal benefits.
"That's why the DEA's interpretation of the law is antiquated," he told Healthline. "Ultimately, Congress must pave the way for the right change in politics and law so that markets, science, and education can do their job."
Eyal Barad, chief executive officer of Cannabics Pharmaceuticals, a biotechnology company that uses artificial intelligence to develop CBD-based cancer therapies, says FDA approval provides legitimacy to the medical cannabis industry.
But to assist in supporting research and development, the federal government must downgrade marijuana planning status.
"The possibilities for cannabis treatments are endless," said Barad Healthline. "There are already research findings showing medical benefits beyond epilepsy, including the fight against cancer, and as more research takes place, its benefits will become even more pronounced."
Lack of physicians
It also raises the question of whether doctors to prescribe marijuana-based medications to their patients.
Dr. Austin-based Aaron Cardon of Child Neurology Consultants said he will "definitely" prescribe Epidiolex to his patients because his "first-in-class" designation means that it works by secreting another mechanism in the brain to seizure others prevent available medications.
"First-in-class drugs are very promising because they provide new combinations for patients whose seizures are not controlled, and thus new freedom of seizure options," Cardon told Healthline.
Sanford Wolgel, PhD, former Chief Scientific Officer of the Cannabistry Labs in Colorado, too often said that doctors do not need to be educated about cannabis and that patients have to go through a difficult trial-and-error process to see what works best for her body.
"Patchwork of Regulation" in the tension between federal and state laws.
"Cannabis policy is changing in the US and will soon lead to legalization at the federal level," he said. "If that happens, it will enable much more academic and medical research on CBD and cannabis."