Medical milestone: US OKs marijuana-based drug for seizures
26 June, 2018, 09:26 | Author: Lillian Steele
As expected, the U.S. Food and Drug Administration on Monday approvedGW Pharmaceuticals PLC-ADR (NASDAQ: GWPH)'sEpidiolex for the treatment of epilepsy, specifically for people who suffer with Lennox-Gastaut and Dravet syndromes. United Kingdom -based GW Pharmaceuticals says the solution, taken by mouth, is made from a proprietary strain of cannabis created to maximize a therapeutic component while minimizing components that produce euphoria.
Today's approval "serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".
"But it's also important to note that this is not an approval of marijuana or all of its components".
The twice-daily oral solution is approved for use in patients 2 and older to treat two types of epileptic syndromes: 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.
Both forms of epilepsy cause severe seizures.
Dr. Anup Patel, neurology section chief at Nationwide Children's Hospital in Columbus, said Monday's announcement is good news for epilepsy patients who have been waiting for relief from the state's 2016 medical marijuana law or have been experimenting with unregulated products claiming to contain CBD.
"This approval is the culmination of GW's many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine", GW CEO Justin Gover said in a statement.
That could accelerate the process of outlawing or allowing new drugs as they pop up.
A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall. The drug should be available in the coming months.
Now that Epidiolex is approved by the FDA, cannabidiol will probably be reclassified by the Drug Enforcement Administration within 90 days.
The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year. The drug reduced seizures by half in 40 percent of Dravet patients participating in the trials. Those taking 20 mg of Epidiolex a day had 42 percent fewer seizures, on average, compared with 37 percent fewer seizures in the group taking 10 mg of the drug, and a 17 percent reduction in the placebo group.
The FDA cites a number of side effects associated with Epidiolex that may give some patients pause, however, including the potential for increased liver enzymes, weakness, poor sleep quality, and diarrhea, among others.
"This is clearly a breakthrough drug for an terrible disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.
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