Women & Children’s Hospital is one of five sites that will study an experimental marijuana compound to treat children and young adults with severe, treatment-resistant epilepsy, the state Health Department announced.
Some studies indicate that GW Pharma’s Epidiolex may help reduce seizures in certain forms of epilepsy.
Patients must be ages 1 to 21, and have tried at least four anti-epileptic drugs without success to be eligible for the trial.
GW Pharma has agreed to make Epidiolex available at no charge for the state-sponsored studies that also include the University of Rochester Medical Center, Montefiore Medical Center, New York Langone Medical Center and Mount Sinai Beth Israel.
Epidiolex is an oil that is 99 percent cannabidiol, a nonpsychoactive marijuana derivative. The compound is not approved by the Food and Drug Administration and is unavailable except through clinical trials, which GW Pharma has been conducting elsewhere in the country to examine the safety and effectiveness of Epidiolex in two epilepsy syndromes known as Dravet and Lennox-Gastaut.
For patients with severe epilepsy, pharmaceutical-grade cannabidiol is the best option, since it allows for accurate dose prescription and titration, Dr. Arie Weinstock, professor of clinical neurology at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo and medical director of pediatric epilepsy, said in a statement.
There could be wide variability between medical marijuana obtained from different dispensaries or even between batches from a single dispensary, he said.
UB researchers working at Women & Children’s Hospital said data gathered by the Epidiolex studies, which will enroll 100 patients in New York State, including 20 in Buffalo, will be used to support an application to the FDA for approval of the drug.
The trials here will investigate how well the cannabidiol compound works when given with existing medications to treat seizures.
Epilepsy is a neurological disorder characterized by seizures. Treatment-resistant epilepsy affects about 35 percent of patients.
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