The chief medical officer at SK Life Science discussed what the clinical community needs to know with cenobamate headed to the market in the second quarter of this year.
Marc Kamin, MD
SK Life Science has announced that its newly approved treatment cenobamate (Xcopri)—indicated for partial-onset seizures in adults—has been designated as a Schedule V agent by the DEA, the lowest designation for abuse from the agency.1
The agent was originally approved by the FDA
for this indication in late November 2019.
That approval supported by data from pivotal trials that assessed the efficacy and safety of cenobamate in more than 1900 total patients. It was shown to significantly reduce partial-onset seizure frequency, with up to 20% of patients achieving seizure-free status during the maintenance phases.2
Its 2 pivotal trials included 655 adults with partial-onset seizures with or without secondary generalization. Patients experienced these seizures for a mean of 24 years, with a median of 8.5 seizures per 28 days during the baseline period of 8 weeks. Patients were randomized to doses of 100, 200, and 400 mg compared to placebo, with the therapy reducing the median number of seizures.3,4
Previously, Marc Kamin, MD, chief medical officer, SK Life Science, told NeurologyLive
that the significant unmet needs for those with epilepsy are a driving force for this therapy’s development. With roughly one-third of the epilepsy patient population not achieving adequate seizure control with the currently available treatments, SK Life Science was hopeful cenobamate can provide an additional option.
To find out what the clinical community needs to know with cenobamate headed to the market in the second quarter of 2020, NeurologyLive
reached out to Kamin.
NeurologyLive: What should the clinical community know about cenobamate before it enters the space later this year?
Marc Kamin, MD:
XCOPRI® (cenobamate tablets) has been approved by the FDA for the treatment of partial-onset seizures in adults. The safety and efficacy of XCOPRI have been demonstrated in two global, randomized, double-blind, placebo-controlled studies and a large, global, multicenter open-label safety study, with more than 1,900 patients enrolled across these studies. In the 2 randomized, double-blind, placebo-controlled phase 2 studies, XCOPRI significantly reduced seizure frequency compared to placebo at all doses studied. XCOPRI will be available in 6 tablet strengths for once-daily dosing: 12.5 mg; 25 mg; 50 mg; 100 mg; 150 mg; 200 mg.
Healthcare professionals and patients should follow the titration instructions and start low (at 12.5 mg/day) and go slow (increase doses every two weeks). A titration pack will provide instructions on titrating at two-week intervals. SK is committed to supporting patients taking XCOPRI and will introduce a new access program to help patients get started and stay on track with their medicine at the time of launch.
What makes this therapy stand out compared to what’s currently available to patients?
We cannot compare to other therapies as there have been no head-to-head trials. Among patients with partial-onset seizures, many continue to have seizures. Our hope is that XCOPRI will provide a new option for these patients.
Transcript edited for clarity
1. SK life science Receives Schedule V Designation from DEA for XCOPRI® (cenobamate tablets) [press release]. Paramus, NJ: Published March 10, 2020. Accessed March 10, 2020. prnewswire.com/news-releases/sk-life-science-receives-schedule-v-designation-from-dea-for-xcopri-cenobamate-tablets-301020783.html
2. FDA approves new treatment for adults with partial-onset seizures [press release]. Silver Spring, MD: FDA; Published November 21, 2019. Accessed March 10, 2020. fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-partial-onset-seizures.
SK life science announces FDA acceptance of NDA submission for cenobamate, an investigational antiepileptic drug [press release]. Fair Lawn, NJ: SK Life Science; Published February 4, 2019. Accessed March 10, 2020. sklifescienceinc.com/pdf/SKLSI%20NDA%20Acceptance%20Press%20Release%20-FINAL-Updated%202-3-19.pdf.
4. Sperling M, Klein P, Kamin M. Safety of cenobamate (YKP3089) as an adjunctive treatment for uncontrolled partial seizures in a large, multi-center, open-label study. Presented at: American Epilepsy Society Annual Meeting; New Orleans, LA; December 2, 2018. aesnet.org/meetings_events/annual_meeting_abstracts/view/500991.