On Monday, June 25, FDA announced that it has approved GW Pharmaceuticals’ Epidiolex (cannabidiol, also known as CBD), an oral solution for the treatment of seizures associated with two forms of epilepsy. It is the first-ever FDA-approved product containing cannabidiol, which remains a Schedule I drug. CBD does not have the psychoactive effects of tetrahydrocannabinol (THC).

The drug is cleared for use in patients 2 years of age and older with Lennox-Gastaut syndrome and Dravet syndrome, both rare and severe forms of epilepsy that inhibit motor development and cause other symptoms that compromise activities of daily living and quality of life.

David Slomski, PharmD, is a pharmacist at the Healing Corner, a medical cannabis dispensary in Bristol, CT. Connecticut requires that a pharmacist dispense medical cannabis. “Pediatric patients with Lennox-Gastaut syndrome and Dravet syndrome have already been benefiting from CBD formulations in states that have medical cannabis programs that allow dispensing to pediatric patients, like Connecticut,” Slomski said. “This will improve access to those patients that live in states where medical cannabis isn't an option.”

Slomski finds it interesting that FDA approved the drug as the CBD extracted from the cannabis plant itself rather than a synthetic form. “We have seen the benefits of these whole plant extracts in medical cannabis programs compared to synthetic forms like dronabinol, so it is nice that FDA is starting to see that there is a legitimate use to the compounds like CBD that can be extracted from the cannabis plant, without causing a euphoric effect.”

In a separate statement, FDA Commissioner Scott Gottlieb, MD, appeared to open the door for further research, which has up to this point been severely hampered by cannabis’s classification as Schedule I—considered to have no legitimate therapeutic value with a high potential for abuse.

Gottlieb emphasized that Epidiolex’s approval followed rigorous clinical research.

“[In] addition to celebrating this scientific achievement and the medical advance that it represents for these patients and their families, we should also reflect on the path that made this possible,” he said. “It’s a path that’s available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs.”

He also said that “FDA remains committed to collaborating with federal and state agencies, researchers and product developers on advancing this type of important and conscientious work.”

In addition to Connecticut, laws require pharmacists to either dispense or supervise the dispensing of medical cannabis in Arkansas, Connecticut, Minnesota, New York, and Pennsylvania. Twenty-nine states allow the use of medical cannabis to varying degrees. ReadPharmacy Today’s January 2018 cover story to learn more on pharmacists’ involvement with medical cannabis.