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The US Food and Drug Administration has approved the first prescription drug derived from the marijuana plant, as a treatment for rare forms of epilepsy that primarily affect children.
The FDA said Monday that it has cleared
GW Pharmaceuticals
Epidiolex from PLC, also known as cannabidiol, to reduce seizures associated with forms of epilepsy known as Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years of age and older .
Cannabidiol is derived from the cannabis plant, also known as marijuana. GW Pharmaceuticals, based in the United States, says the solution, taken orally, is made from an exclusive cannabis strain designed to maximize a therapeutic component while minimizing the components that produce euphoria. GW Pharmaceuticals grows plants in the UK.
The FDA said on Monday that the drug does not cause the high that comes from the chemical tetrahydrocannabinol, or THC, which is the main psychoactive component of marijuana. FDA officials also said the drug does not appear to have any potential for abuse, citing minimal reports of euphoria in patients who took the drug in clinical studies.
The FDA's action follows the growing interest in the medical uses of marijuana. Since the 1990s, some 30 states and the District of Columbia have legalized the medical use of marijuana, according to the National Conference of State Legislatures. In addition, some states have specifically legalized the medical use or clinical testing of cannabidiol. But products sold under these laws have not yet received FDA approval.
"This approval reminds us that promoting strong development programs that properly value the active ingredients in marijuana can lead to important medical therapies," FDA Commissioner
Scott Gottlieb
I said.
Dr. Gottlieb also warned in a conference call that the agency would take action against any illegal marketing of products containing cannabidiol with serious and unproven medical claims. According to him, some companies have marketed cannabidiol, or CBD oil, against diseases such as cancer, which he says could lead to patients giving up proven effective treatments for these diseases.
In clinical studies sponsored by the company, cannabidiol has reduced the frequency of seizures in patients. In a study of 120 children and young adults with Dravet syndrome, cannabidiol reduced the median seizure frequency to 5.9 per month compared to 12.4 before treatment, while patients receiving placebo experienced minimal reductions. of Medicine.
The drug is associated with certain side effects, including gastrointestinal problems and abnormal liver function test results. But FDA officials said that they thought the risks were manageable if a warning was placed on the drug's prescription label, and if the agency was monitoring the liver risk after the drug either on the market.
In April, an advisory committee of the FDA voted unanimously that the risk-benefit profile of Epidiolex was favorable.
Several parents of children with epilepsy testified before the panel, saying that cannabidiol helps reduce seizures and improve quality of life.
The LGS Foundation estimates that there are between 30,000 and 50,000 Americans with Lennox-Gastaut Syndrome. GW Pharma says that about 6,000 to 10,000 have Dravet syndrome.
GW Pharmaceuticals said it was expecting to make the product available in the fall, pending action by the Drug Enforcement Administration to reclassify the drug. There is currently a Schedule 1 drug, as well as heroin, because of the risks of abuse, but GW expects Epidiolex have a less restrictive AED schedule due to studies demonstrating minimal abuse potential and now approved medical use.
GW Pharmaceuticals General Manager
Justin Gover
said in an interview, the company has not yet set a price. He said the company would deploy about 70 sales representatives to promote the drug to doctors specializing in severe epilepsy.
"Now that the FDA has approved this drug, it allows us to talk about Epidiolex in the context of a new approach to the treatment of epilepsy," he said. "In this regard, we are now turning to what this product does as opposed to what this product is."
Mr. Gover said that he expected other cannabidiol preparations to remain available in states where they are legal. It is the responsibility of the relevant health authorities and agencies to monitor the marketing of competing versions of Cannabidiol that are not approved by the FDA. He noted that the FDA-approved prescription label for Epidiolex describes the safety and effectiveness of this drug and not other forms of cannabidiol.
"It is not in our interest to have an impact on these laws and companies," he said. "The only question for us that was relevant is that medical claims must be made only for products that have received FDA approval."
Write to Peter Loftus at [email protected]
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