The drug's approval permits https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf its use in patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.
A statement from the UK-based GW pharmaceutical company said, "First pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs". Earlier this year, an expert advisory panel for the FDA voted unanimously to recommend Epidiolex's approval and stated that "CBD has a negligible abuse potential". Davert syndrome is a genetic dysfunctin of the brain that begins in the first twelve months of life.
"This is an important medical advance", FDA Commissioner Scott Gottlieb said.
Epidiolex is made of CBD (cannabidiol), a cannabis chemical compound of marijuana that does not cause tightness.
It has high mortality rate than other types of epilepsy and do not respond to any other drugs available.
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The drug is the only treatment officially approved to treat Dravet syndrome. The report by Stat goes on to add that analysts predict the drug might be used to treat forms of epilepsy other than DS and LGS.
The DEA's stance that any extract from the Cannabis sativa plant is classified as Schedule I was recently upheld by the 9th U.S. Circuit Court of Appeals.
During clinical trials, the researchers were able to observe the following effects: sleepiness, sedation, lethargy, fatigue, elevated liver enzymes, decreased appetite, diarrhea, rash, malaise, weakness, insomnia, poor quality sleep, and various infections. "The conditions it is approved to treat are devastating and hard to control and so rightly got the attention of pharmaceutical companies and regulatory agencies", he says. "This is the approval of one specific CBD medication for a specific use", Gottlieb said. But that is not necessarily the case and readers with an interest in this drug would be better informed if some of the clinical trial evidence had been included in the story.
In the press announcement, FDA stated that Epidiolex must be dispensed with a patient Medication Guide that details information about the drug's uses and risks. Interestingly, the warning focused not on the products' CBD content as violative of the CSA, but instead on the unproven and potentially fraudulent nature of the product's marketing representations. "In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition".
According to the Medical Cannabis Market report published by Coherent Market Insights, Increasing approval of medicinal cannabis products and growing research and development activities in the medical cannabis market are expected to support the development of novel drugs for treatment of various disorders.