The director of the Jefferson Comprehensive Epilepsy Center and the Jefferson Clinical Neurophysiology Laboratory spoke to the therapy’s success thus far.
Michael Sperling, MD
Cenobamate was recently assessed in a safety trial of more than 1300 patients with epilepsy to determine if a low-dose, slow titration strategy could prevent the incidence of drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, which was positive.
In that trial, which was presented at the American Epilepsy Society’s 72nd annual meeting, in New Orleans, Louisiana, the treatment displayed no cases of DRESS, which Marc Kamin, MD, the chief medical officer at SK Life Science, the therapy's developer, told NeurologyLive was “extremely encouraging.”
Although the sodium channel antagonist may not be particularly different from the currently available therapies, it has shown promise in trials thus far, though phase 3 data has yet to be reported. Michael Sperling, MD, the director of the Jefferson Comprehensive Epilepsy Center and the Jefferson Clinical Neurophysiology Laboratory and an investigator in the therapy’s clinical trial program, told NeurologyLive in an interview that cenobamate has shown promise.
To find out more about the trial, the therapy itself, and its future, NeurologyLive discussed the treatment with Sperling.
Michael Sperling, MD: It was good to learn that we had no cases DRESS with the more gradual titration schedule. We were all very concerned about that possibility and were glad to see it did not happen. Putting this in context with other drugs, any medication can occasionally cause an allergic response in some individuals. Some other medications, such as lamotrigine, carbamazepine, and phenytoin, for example, which are commonly prescribed to large numbers of people, also have been reported to have potentially serious or life-threatening skin reactions. Cenobamate is like other drugs—none are absolutely safe, and no drug is perfect. I It appears to be reasonably safe after viewing the results of this phase 3 study and I look forward to a careful evaluation by the FDA.
I believe the company has submitted an NDA to the FDA requesting approval of the drug. I would imagine that a monitoring regimen will be implemented to track the incidence of DRESS syndrome and other serious skin rashes that may occur. The surveillance program would likely be implemented by SK Life Science. Once the drug is approved and prescribed to large numbers of people, we should have a much better estimate of the risks.
It's not unique. This drug, based on my opinion after treating more than 60 patients, is the most startlingly effective anticonvulsant drug that I've ever used in an investigational trial. I've been involved investigational trials since the late 1980s and this one remarkably reduces seizure frequency and seizure severity. I have seen a number of patients who have become seizure-free after starting this drug.
Transcript edited for clarity.