Xcopri gives long-term seizure management in sufferers with focal epilepsy

June 23, 2022

2 min learn

Disclosures: Klein is employed by Mid-Atlantic Epilepsy and Sleep Heart. Please see the examine for all different authors’ related monetary disclosures.

Lengthy-term use of Xcopri was secure and lowered seizures by greater than 90% in adults with uncontrolled focal seizures, in accordance with outcomes of an open-label extension examine printed in Neurology.

“The findings present that the notable enchancment in seizure management that was seen in sufferers with uncontrolled focal epilepsy is sustained over long run,” Pavel Klein, MD, lead examine creator and epileptologist and neurologist at Mid-Atlantic Epilepsy and Sleep Heart in Bethesda, Md., instructed Healio. “The examine reveals {that a} important proportion of sufferers with uncontrolled epilepsy proceed to stay seizure-free or have no less than 90% discount for a time frame that sustained over the length of the examine — for years.”

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Klein and colleagues performed a randomized, double-blind, placebo-controlled examine of Xcopri (cenobamate, SK Life Science Inc.) and assessed knowledge from 355 grownup sufferers with focal seizures that had been uncontrolled regardless of being handled with as much as three antiseizure drugs.

In response to a press launch concerning the examine findings from SK Life Science, individuals, who had no less than eight seizures through the 8-week baseline interval, accomplished the 18-week, double-blind part and continued into the open-label extension.

The median remedy length of cenobamate was 54 months (200 mg median each day dose, starting from 50-400 mg). As of July 2019, 59% of sufferers (209 of 355) continued remedy.

Throughout any 12-month interval of the examine, 13% to 16% of sufferers achieved seizure freedom, and amongst these, the median seizure-free length throughout every 12-month interval was 48 months, 47.2 months and 45.1 months, the corporate reported within the launch.

The examine confirmed that each one sufferers taking cenobamate skilled a median % seizure frequency discount over baseline that elevated with every 6-month interval, as much as 76% throughout months 43 to 48 of the examine. Researchers additional reported that 16.4% of sufferers achieved 100% seizure discount throughout 36 to 48 months, and 39.1% of sufferers achieved greater than 90% seizure discount throughout the identical interval.

SK Life Science stated within the launch that no new issues of safety had been reported. Remedy was discontinued in 141 sufferers, with the most typical causes being a scarcity of efficacy (17%), withdrawal by affected person (9%) and antagonistic occasions (8%). The commonest treatment-related antagonistic occasions had been dizziness, somnolence, fatigue and headache.

“The conclusion that we now have a medicine that may result in sustained seizure freedom for sufferers with uncontrolled focal epilepsy could be very thrilling and life-changing for sufferers who’ve that response,” Klein stated. “It’s a fantastic factor to have the ability to supply to sufferers.”

Reference:

Lengthy-term efficacy and security knowledge of Xcopri (cenobamate tablets) CV printed in Neurology. https://www.sklifescienceinc.com/pdf/Long_Term_Efficacy_and_Safety_Data_of_XCOPRI%C2%AE_cenobamate_tablets_CV_Published_in_Neurology.pdf. Printed June 22, 2022. Accessed June 23, 2022.

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