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Laura J. Martin, MD
April 13, 2011 -- An experimental epilepsy drug may help reduce seizures in as many as one-third of people with epilepsy who either don’t tolerate or don’t respond adequately to existing seizure drugs.
The finding is slated to be presented at the 63rd Annual Meeting of the American Academy of Neurology in Honolulu.
The new drug, perampanel, works by blocking chemical receptors in the brain that may play a role in epilepsy. The new study was supported by perampanel manufacturer Eisai Inc.
Of 387 people with uncontrolled epilepsy who were taking one to three other seizure drugs, those who took 8 or 12 milligrams of the new agent for 19 weeks along with their regular treatment showed a greater reduction in seizures, compared with those who received a placebo pill in addition to their regular treatment.
Those who took the 12-milligram dose of perampanel had a 14% reduction in seizures in a 28-day period compared to those who took placebo. Those who took the 8-milligram dose of the new drug reduced their seizure frequency by nearly 6% compared to those who took the placebo.
Perampanel side effects included dizziness, drowsiness, irritability, headache, falls, and ataxia (lack of muscle coordination).
The company plans to submit the drug for FDA approval this year. “If this drug is approved by the FDA, it will be another tool in our arsenal for combating or reducing seizures in people with difficult-to-treat epilepsy,” says study researcher Jacqueline French, MD, a neurologist at New York University in New York City, in a news release.
This drug may prove to be a valuable addition for people with hard-to-treat epilepsy, says Steven Pacia, MD, chief of neurology at Lenox Hill Hospital in New York City.
“If we can demonstrate efficacy, safety, and tolerability, it’s worthwhile to have another drug that works in difficult patients with difficult seizures,” he says.
“This will be the first group of people it is used on, if approved,” Pacia says. “If it has a broader role, we will find out after that when it has been used by more people for longer periods of time.”
“While the reduction in seizures seen in the new study was small percentage-wise, it can mean the difference of having a seizure that causes falling and one that doesn’t, and that can be a big difference,” he says.
This study was presented at a medical conference. The findings should be considered preliminary as they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.
SOURCES:63rd Annual Meeting of the American Academy of Neurology, Honolulu, April 9-16, 2011.Steven Pacia, MD, chief of neurology, Lenox Hill Hospital, New York City.News release, American Academy of Neurology.
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