U.S. approves 1st prescription drug made from Marijuana

Posted by Sagar Satapathy on June 26, 2018.

In a nationwide first, the U.S. health regulators Monday approved prescription drug made from marijuana.

The U.S. Food and Drug Administration approved the medication, called Epidiolex.

Epidiolex will be legally used to treat Lennox-Gastaut syndrome and Dravet syndrome, two serious and rare kinds of epilepsy.

It is considered as a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

According to the FDA, Epidiolex, a strawberry-flavored syrup, is the first approved treatment for Dravet syndrome.

Epidiolex which is also known as cannabidiol, or CBD, is extracted from marijuana sativa plants. But it does not produce the high typically associated with marijuana because it does not contain the psychoactive ingredient THC.

CBD oil is currently sold online and in specialty shops across the U.S., though its legal status remains murky.

FDA Commissioner Scott Gottlieb in a statement said, “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.”

The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few treatments. But doctors will have the option to prescribe it for other uses.

Since both Lennox-Gastaut syndrome and Dravet synonym appear in early childhood, Epidiolex is legal in treatment for patients two-year-old and above. Both syndromes feature uncontrollable and severe seizures resulting in some form of learning disability, such as hindered languages and motor skills.

As per the FDA, sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections are some side effects presented in the clinical trials.

Because of its relation to marijuana, CBD is currently considered a Schedule I drug. Trials were conducted to examine the abuse potential of CBD.   

Nine states and the District of Columbia have legalized marijuana for recreational use. Another 20 states allow medical marijuana, but the U.S. government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

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