FDA Gives Approval for Marijuana Oil Study - Higher Education

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FDA Gives Approval for Marijuana Oil Study

by Kim Chandler, Associated Press

MONTGOMERY, Ala. ― The Food and Drug Administration has given the University of Alabama at Birmingham permission to study the use of a marijuana derivative to treat seizures.

Parents of children with seizure disorders persuaded the Alabama Legislature last year to pass a bill authorizing UAB’s Department of Neurology to do a study of the marijuana derivative cannabidiol, or CDD oil, as a potential treatment for seizures. UAB spokesman Bob Shepard said the university received FDA letters on Wednesday authorizing the two studies, one for children and one for adults.

Shepard said the FDA requested some changes. Those will go before a university review board next month, he said.

The federal approval was welcome news to families who had pushed to make the oil legally available in Alabama.

“It’s hard to put in words the feelings you have as a Dad with a daughter that could benefit from this,” said Dustin Chandler.

The legislation became known as “Carly’s Law” on behalf of Chandler’s 3-year-old daughter. Carly Chandler started having seizures at just 8 weeks old. She was eventually diagnosed with CDKL5, a rare genetic disorder. Chandler, a police officer from Pelham, made frequent appearances at the Alabama Statehouse to lobby for the bill.

He and other parents said there is anecdotal evidence that the oil can reduce the severity and frequency of seizures.

Chandler said he is thrilled that the treatment option will now be available, not only for his daughter, but for others who are suffering.

“I’m relieved that we got over this big hurdle and excited that the study is finally going to proceed,” Chandler said.

Alabama lawmakers approved the study after a decriminalization bill, which would have shielded parents and patients from prosecution if they bought the oil on their own, stalled under concerns about patient safety and opposition to any form of medicinal marijuana.

The approved legislation gives $1 million to the university to fund the five-year study and determine the effectiveness as a treatment. Participants in the study who are prescribed the marijuana oil will have legal protection from state criminal charges.

Unlike studies in which some patients are given placebos, the UAB study will provide the oil to all participants. Chandler said he hopes families can get the oil beginning in early 2015.

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