FDA approves first prescription drug made from marijuana

According to The Associated Press, U. S. health regulators on June 25 approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

The Food and Drug Administration (FDA) approved the medication, called Epidiolex, to treat two rare forms of epilepsy that begin in childhood.  But it’s not quite medical marijuana.

The strawberry-flavored syrup is a purified form of a chemical ingredient found in the cannabis plant — but not the one that gets users high.  It’s not yet clear why the ingredient, called cannabidiol, or CBD, reduces seizures in some people with epilepsy.

British drugmaker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis.   FDA officials said the drug reduced seizures when combined with other epilepsy drugs.

Epidiolex is essentially a pharmaceutical-grade version of CBD oil, which some parents already use to treat children with epilepsy.  CBD is one of more than 100 chemicals found in marijuana.  But it doesn’t contain THC, the ingredient that gives marijuana its mind-altering effect.

Side effects with the drug include diarrhea, vomiting, fatigue and sleep problems.

CBD oil is currently sold online and in specialty shops across the U. S., though its legal status remains murky.  Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.

FDA Commissioner Scott Gottlieb suggested the agency would be scrutinizing CBD products with “uncertain dosages with formulations.”   “We are prepared to take action when we see the illegal marketing of CBD containing products with serious, unapproved medical claims,” Gottlieb said.  The FDA previously issued warnings to CBD producers that claimed their products could treat specific diseases, such as cancer or Alzheimer’s.   Most CBD producers side-step the issue by making only broad claims about general health and well-being.

A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall.   Wall Street analysts have previously predicted it could cost $25,000 per year, with annual sales eventually reaching $1 billion.

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.  Bus doctors will have the option to prescribe it for other uses.