The University of Cincinnati expects to begin a study regarding certain types of epilepsy drugs in March.
“The FDA, last year, decided that they would fund the study to look at how much difference there is between generic drugs and brand name drugs,” said Michael Privitera, a neurologist at UC and the principle investigator of the study. “Some doctors and some patients have complained that when [people with epilepsy] switch from the brand name drug to the generic drugs that they were losing control of the seizures or they were having too many side effects.”
The FDA believes there is enough research for doctors to trust generic drugs to be as effective as the name brand drugs.
“What we’re really testing is whether the FDA protocol to test generic drugs really works in the real world with people with the disorder taking a lot of other medicines,” he said. “When the FDA tests generic drugs, it tests them in normal volunteers, which is a big difference because a lot of these people with epilepsy may be taking three, four or five drugs at a time.”
Approximately $2.6 million in funds will be allocated for the study, Privitera said.
Approximately $1.6 million came from the FDA and $500,000 from the American Epilepsy Society and the Epilepsy Foundation.
“Majority of the money goes to the blood testing and testing of the different generic products in the lab,” Privitera said.
The study will be conducted at several different sites but led by Privitera at UC and Michael Berg, a medical professional at University of Rochester.
“The majority of the money will be distributed based on the number of patients in the study [at each site],” Privitera said.
UC expects the study to take 15 to 18 months to complete, Privitera said.