FDA Grants ‘Priority Review’ Of Plant-Derived CBD Extract

DISTRICT OF COLUMBIA: Representatives of the US Food and Drug Administration will undertake a ‘priority review‘ of data specific to the safety and efficacy of Epidiolex, a standardized, plant-derived CBD extract formulated by a British pharmaceutical company. The review is scheduled to be completed by June 27, 2018.

Phase III clinical trial data shows that Epidiolex administration reduces seizure frequency in various hard-to-treat conditions, such as Lennox-Gastaut syndrome and Dravet syndrome.

To date, the FDA has approved three marijuana-based pharmaceuticals – dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid dronabinol (aka Syndros). All three of these products primarily consist of synthetic forms of THC.

If Epidiolex achieves FDA-approval, analysts suggest the product could retail for between $30,000 to $60,000 annually.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org.

Study: Marijuana Use Linked To Lower Prevalence Of Fatty Liver Disease

MASSACHUSETTS: Subjects who consume cannabis are significantly less likely to suffer from non-alcoholic fatty liver disease (NAFLD) as compared to those who do not, according to population-based case-control data published in the journal PLOS One. Non-alcoholic fatty liver disease is the most prevalent form of liver disease in humans, affecting an estimated 80 to 100 million people in the United States.

A team of researchers from the University of Massachusetts Medical School and John Hopkins University in Baltimore assessed the relationship between cannabis use and NAFLD in a nationally representative cohort of 5.9 million hospitalized patients ages 18 or older.

Authors reported that the prevalence of NAFLD was 15 percent lower in occasional marijuana users than it was in non-users. More habitual cannabis consumers were 52 percent less likely to be diagnosed with the disease as compared to abstainers.

Researchers concluded, “We observed a strong dose-dependent reduction in the prevalence of NAFLD with cannabis use suggesting that cannabis use might suppress or reverse NAFLD development.”

Separate case-control studies have previously reported an inverse association between cannabis use and obesity and adult onset diabetes, both of which are risk factors for NAFLD.

For more information, please contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Cannabis use is associated with reduced prevalence of non-alcoholic fatty liver disease: A cross-sectional study,” appears in PLOS One.

Fact: Daily Marijuana Users Are As Healthy As Non-Smokers

SWITZERLAND: Cannabis is a “dangerous and addictive” drug, say proponents of ongoing pot prohibition.

But daily tokers don’t seem to have higher levels of health problems, emergency department use or hospital stays than people who don’t smoke pot, according to a new study in the Journal of Internal Medicine this month. [Read more…]