Landmark Moment As The FDA Approves Cannabis-Based Drug For First Time In History
By Roger Malespin photo/istock/Ildo Frazao
In a move that was expected since it passed clinical trials in April, and was recommended unanimously by an FDA advisory committee, the Food and Drug Administration has approved Epidiolex, a cannabis based drug for treating severe forms of epilepsy. This is the first time in history that the FDA has approved a cannabis based drug for public use. The approval is a reflection of the shifting American social consciousness on cannabis acceptance, and will also go a long way in giving pro legalization politicians trying to pass legislation at the federal level.
Epidiolex is approved for patients 2 years and older, focusing on 2 types of epilepsy: Dravet syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begin in early childhood, usually between 3 and 5. The drug is manufactured by GW Pharmaceuticals PLC, a UK-based bio-pharmaceutical company.
"We're obviously very pleased by the unanimous recommendation in support of the approval of Epidiolex," GW CEO Justin Gover said. "It's a very important milestone in the approval process."
As many as one third of families who have a member with epilepsy have said that no current treatment is helpful for their seizures, which is about 1 million people. While Epidiolex is recommended with epilepsy patients in mind, doctors do have the option to prescribe it for other uses, including cancer pain relief, should they see fit.
Gover added, "These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care."
The drug will become available in the fall, but naturally there are a couple of legit concerns. It’s is unclear what the cost will be or how it will be covered under insurance. Those things will be negotiated with insurance companies, but given the state of our medical care industry in America it’s unfortunately a safe bet to think it will be expensive.
Another less prominent concern are the side effects. So far, the biggest side effect is sleepiness, but it has shown to be problematic when taken with other medications, which the majority of epilepsy patients are on. Sleepiness is on the lower end of side effect concerns though, and potential users have little to fear because the benefits far outweigh the downside.
Of all the victories that the legalization movement has achieved over the past few years, this might be the most significant. It cannot be stressed enough how big a deal it is for the federal government to formally recognize the medical benefits of cannabis, which has long been unfairly demonized in American politics. During a time when the White House has repeatedly said they are willing to review the federal stance on cannabis, the approval of Epidiolex could very well be the tipping point. Cannabis is finally being recognized as a legitimate medical option, which is long overdue. Epilepsy patients and legalization advocates of all kinds have good reason to celebrate today - the days of cannabis being illegal are closer than ever to coming to an end.