FDA Approves Drug Derived from Marijuana
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FDA Approves Drug Derived from Marijuana
Posted by CN Staff on June 25, 2018 at 13:21:57 PT
By Tom Howell Jr., The Washington Times
Source: Washington Times
Washington D.C. -- For the first time, the U.S. government on Monday approved a drug with ingredients derived from marijuana, paving the way for research into similar products.The Food and Drug Administration said Epidiolex, which treats seizures from rare types of epilepsy, contains a chemical from marijuana known as cannabidiol, though it won’t produce the “high” associated with the common street drug.
The intoxication linked to marijuana comes primarily from a chemical known as “THC.”The FDA said British drugmaker GW Pharmaceuticals conducted studies to verify their product wouldn’t result in abuse, since marijuana itself is a scheduled drug with a potential for abuse under federal law.“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb said.“This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components,” he said. “This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition.”Dr. Gottlieb said interest in the development of marijuana-related therapies has been growing over the past decade, and that drugmakers interested in the field will find a “robust clinical development program” at his agency.However, he said the FDA will subject these products to careful, science-based reviews and watch out for the illegal marketing of unapproved products with cannabidiol, or “CBD.”Epidiolex is an oral solution that consists of plant-derived CBD.It will be used by patients with Lennox-Gastaut and Dravet syndromes, which can develop in childhood and often result in seizures and developmental problems, such as poor motor skills.The drug is the first one approved for Dravet, so it was granted a fast-track review by the FDA.GW Pharmaceuticals hailed the approval as “a historic milestone” that caps years of hard work with patients, families and their doctors.“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,” company CEO Justin Gover said.Source: Washington Times (DC)Author:  Tom Howell Jr., The Washington TimesPublished: June 25, 2018Copyright: 2018 News World Communications, Inc. Website: letters washingtontimes.comURL: Medical Marijuana Archives 
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