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Marijuana-based drug could get FDA approval

A new drug to help kids who have seizures is a step closer to FDA approval.

BUFFALO, N.Y. — A new drug to help kids battling severe forms of epilepsy is one step closer to FDA approval.

If that happens, it will become the first marijuana-based drug approved for childhood seizures.

University at Buffalo Professor Dr. Richard Blondell is hopeful that after 40 years of testing — starting with rats in 1977 — the FDA will approve a cannabis-based oil to treat two rare forms of epilepsy.

A panel of advisors at the FDA unanimously voted Thursday to recommend the FDA approve Epidiolex for use in the United States.

"The way to approve drugs in the Unites States is to study them in animal models, begin to test them in humans, do good clinical trials, with a specific dose of a medication for a specific indication, and see if it really does help," Dr. Blondell said.

The drug would be used to treat two rare types of epilepsy in patients two and older. Lennox-Gastaut Syndrome affects an estimated 1 in 50,000 to 1 in 100,000 children. Dravet Syndrome affects an estimated 1 in 15,700 people.

"For parents, it is heart-wrenching and very emotional to watch a kid have a seizure," Dr. Blondell said. "Something that can decrease the frequency of seizures or eliminate them altogether, is going to be a godsend for certain patients and certain parents."

In order to help more people with different medical issues benefit from marijuana-based medicine, Dr. Blondell says one big change needs to happen.

"What we really need to do is reclassify marijuana and turn the drug companies lose on it so they can begin to isolate these chemicals, study it, and find drugs that might help with chronic pain, depression, sleep disorders, seizures, but I think we need to do it in a measured, scientific, medical way, and not some, on a political whim," he said.

The FDA is expected to make a final decision about whether to approve the drug by June 27. If approved, the drug company says it hopes to make it available by the end of the year.

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