The FDA just approved Epidiolex, the GW Pharma seizure drug derived from cannabis, giving children with two rare and serious forms of epilepsy a new treatment-and companies looking to develop marijuana-based drugs a model for their own path to market.
The move marks several firsts. GW Research Ltd., the London-based company who produced Epidiolex is also expecting another decision that will require reclassifying CBD and allowing other marijuana-derived medications as well as reducing limitations on marijuana-related research.
The FDA approved the first drug with an active ingredient derived from marijuana to treat rare, severe forms of epilepsy.
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"This is an important medical advance", FDA Commissioner Dr. Scott Gottlieb said in a statement Monday.
The drug, which will become available this fall, will hopefully be a wonderful option for parents of epilepsy patients who have, until now, had their hands tied when it comes to improving their kid's quality of life. In the Phase 3 published studies, EPIDIOLEX® added to other antiepileptic therapies significantly reduced the frequency of seizures in patients with Dravet Syndrome and LGS.
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.
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The drug is made from purified cannabidiol, or CBD, a wondrous compound found in the cannabis plant. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications. They're not regulated the way pharmaceutical drugs are, so the consistency and dose can vary widely. And Epidiolex could well be the first in a wave of marijuana-based therapies; agency officials said they have implemented regulatory processes to help drug developers test marijuana or its components in their own clinical trials.
Gaer said she's been using a particular CBD oil with her daughter since it's been legal in Iowa, and she's not sure about this new drug.
Shauna Garris, a pharmacist, pharmacy clinical specialist and adjunct assistant professor at the University of North Carolina's Eshelman School of Pharmacy, said the drug is effective and works somewhere between "fairly" and "very well". "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits", Gottlieb said.
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