XCOPRI (cenobamate tablets), an anti-epileptic drug, gets the acceptance of U.S. Food and Drug Administration for managing partial-onset seizures. FDA has given the approval of this drug to SK Life Science Inc.
According to the FDA’s Office of Neuroscience’s director, Billy Dunn, in adults, it is difficult to control partial-onset seizures that can significantly affect a person’s quality of life. In such a condition, XCORPI is a new light of hope, as it may treat these seizures.
Different seizure medicines available in the market show different responses in the patients. In this dilemma, the approval of XCORPI acts as another treatment option for people suffering from partial-onset seizures.
In the brain, abnormal electrical activity usually for a short time period leads to seizures. Seizures can further cause abnormal behavior or thinking abnormal sensations, or uncontrolled movements. If the movements become violent, it can also lead to alterations in the consciousness level.
In the brain, neurons undergoing uncontrolled activation causes seizures to occur. Whereas partial-onset seizure is the one that arises in a limited area. The efficacy and safety of the drug XCORPI were observed by two-randomized trials.
These placebo-controlled and double-blinded studies enrolled nearly 655 adults. The partial-onset seizures in these adults occur with or without secondary generalization. On average, these seizures occur for nearly 24 years, with a median frequency of about 8.5 seizures every 28 days.
When compared to the placebo group, daily XCORPI dosages of 100, 200, and 400 mg during the trials lead to a reduction in the seizure percentage per 28 days. Whereas, following a medication adjustment (titration) period, 200 mg per day was indicated as the XCORPI’s suggested dose.
But, on the basis of tolerability and clinical response, some patients may require an additional titration to 400 milligrams per day (maximum recommended dosage). Some patients taking XCORPI reported multiorgan sensitivity, also known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms).
The rapid titration of XCORPI led to DRESS in some patients. Additionally, it also caused the death of a person. However, in an open-label study including 1,339 patients of epilepsy, no DRESS associated cases were found with XCORPI starting dose of 12.5 mg daily, which was further adjusted every two weeks.
But still, it doesn’t prove that a slower titration can prevent the risk of DRESS. When compared to placebo, many of the patients taking XCORPI also reported a reduction in QT interval by 20 milliseconds.
Patients having Familial Short QT syndrome, or hypersensitivity to cenobamate or any of the XCORPI’s inactive ingredients should avoid the use of XCORPI. Whereas, a serious heart problem – ventricular fibrillation, maybe the reason behind QT shortening.
Further, an increase in the risk of suicidal thoughts was also observed by the use of antiepileptic drugs (AEDs) like XCORPI. So, the patients using these drugs should be continuously observed for the development or worsening of any unusual changes in mood or behavior, suicidal thoughts or behavior, or/and depression.
In these clinical trials, some adverse effects associated with XCORPI like neurological adverse reactions were also reported. Among these, the most common were fatigue, headaches, diplopia (double vision), dizziness, and somnolence (sleepiness).
So, the patients are recommended to avoid operating machinery or driving until the effect of XCORPI exists. SK Life Sciences has been granted the approval of this anti-epileptic drug.