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FDA approves first marijuana-based drug Epidiolex for epilepsy patients

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The marijuana-based prescription medication Epidiolex has just received FDA approval and might be available as early as this fall to patients suffering from two forms of severe epilepsy. The medication manufactured by the London-based company GW Pharmaceuticals is designed to reduce or prevent the number and severity of grand mal seizures commonly associated with Lennox-Gastaut and Dravet syndromes of epilepsy.

These seizures can often be life-threatening, and in many cases, the more intense occurrences can lead to physical impairments, cognitive infirmities, learning disabilities, emotional disorders, and even abnormal brain development in younger patients.

News of the FDA approval comes on the heels of a recent press release by the U.S. Drug Enforcement Agency (DEA) stating that cannabis-derived products like cannabidiol or CBD will soon be eliminated from the list of federally controlled substances. Furthermore, legislation pushed by Senate Majority Leader to legalized hemp passed the senate by a vote of 86-11 on June 28, 2018. While marijuana remains illegal at the federal level, about 30 states across the nation have successfully lifted their associated bans so far.

Due to the United States’ participation in multiple international drug treaties, the likelihood of marijuana legalization at the national scale remains fleeting – at least for the time being. On the other hand, Canada – who also participates in these same treaties – just legalized marijuana as of a few short weeks ago. However, the Russian Government has also recently called Canada’s actions a violation of international law. As a result, the Russia-friendly Trump Administration may be wary of entering into such a politically-charged debate.

FDA Chief Scott Gottlieb weighs in

According to the FDA approval guidelines, physicians can prescribe the orally-ingested medication Epidiolex to patients over the age of 2. The medical community estimates that some 45,000 patients in the United States alone might benefit from this treatment and subsequently experience a vastly improved quality of life. Insiders are hopefully optimistic that the FDA will eventually expand Epidiolex’s prescription criteria to include several additional forms of epilepsy in the very near future, potentially helping millions more.

“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 via press release

The FDA has been toying with the ideal of approving marijuana-based medications for several years. In fact, the public health agency has already approved several prescription drugs utilizing synthetic tetrahydrocannabinol or THC, the chemical found in cannabis that scientists claim instigates the medicinal and therapeutic benefits. One such example is the hemp-derived Charlotte’s Web, also proven to be instrumental in helping reduce the severity and frequency of grand mal seizures associated with many forms of childhood epilepsy.  

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