By BECKY GILLETTE
Research is being done at the University of Mississippi Medical Center (UMMC) and the UM School of Pharmacy on the effect of the cannabis-derived medicine cannabidiol (CBD) on children with seizures. An initial six-month CBD trial UMMC received a one-year extension in late July.
CBD is a non-psychoactive chemical compound derived from cannabis. CBD doesn’t impair thinking or cause intoxication like other cannabis chemicals such as tetrahydrocannabinol (THC). CBD is legal at the federal level, and has been growing in popularity for uses such as pain relief. The Hemp Business Journal estimates that there were $500 million in CBD sales in the U.S. in 2018.
The CBD in the UM trial is grown at the UM School of Pharmacy’s National Center for Natural Products Research (NCNPR). Multiple approvals were required from the Food and Drug Administration and Drug Enforcement Agency for the trial of 10 patients that begin in 2018. All ten patients in the initial trial opted to participate in the extension.
Dr. Brad Ingram, principal investigator in the trial, a UMMC associate professor of pediatric neurology and director of the UMMC Pediatric Comprehensive Epilepsy Program, described treatment with the drug as “compassionate care for the sickest of the sick.” He said they found no significant safety issues during the trial’s first six months and results so far have been promising.
“Some of the trial participants are at the status quo, and some have had a really good response to the drug,” Ingram said. “All of the participants, though, seem to have some positive outcome, such as more pleasant mood or sleeping better. Even with patients whose seizure counts are unchanged, parents said their children are happier. We had a teenage patient say ‘mom’ to the patient’s mother for the first time ever. We had patients whose parents were able to take them to the grocery store for the first time.”
Ingram said participants in the trial have been devastated by their epilepsy, even up to their abilities to walk, talk, or participate in simple activities of self-care.
Dr. Richard Summers, UMMC associate vice chancellor for research, said the FDA extension of the study is a next great step toward developing this natural product into a therapeutic with the promise of controlling seizures in many patients who have failed to recover with conventional treatment.
“The allowance of an extension is also a reflection of the great success of our initial trial and the quality of the research operations of the UMMC CBD team,” Summers said. “We are hoping to use these efforts as a springboard for other future potential areas of use for this compound.”
NCNPR Director Emeritus Dr. Larry Walker said they have been pleased to see how the patients and their families have benefited from the study, and are hopeful that another year will provide a basis to begin a development program of a federally approved cannabis-based botanical drug.
In the trial, extracts of a marijuana strain grown on the UM Oxford campus are being manufactured, packaged and checked to ensure all quality control specifications are met before being transferred to the pharmacy at UMMC’s main campus in Jackson. There, the extract is diluted with pharmaceutical-grade sesame oil to achieve the proper dosage concentration.
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