A decision from
'This is an important step in our journey to address the unmet needs of adult patients diagnosed with partial-onset seizures,' said
The regulatory submission includes efficacy information from two pivotal studies (C013 and C017)1,2, which enrolled a total of 658 patients. The evaluation of safety was conducted over the course of the two pivotal studies, and their respective open-label extensions, and is complemented by a long-term open-label Phase III safety study (C021)3, also presented in the regulatory submission. A total of 1,944 patients with epilepsy have been treated with cenobamate in the clinical development program.
About Cenobamate
Cenobamate is a novel small molecule with a dual mechanism of action under investigation for treating seizures.4,5,6 Cenobamate, at clinically relevant concentrations, acts both as a positive allosteric modulator of the ?-aminobutyric acid (GABAA) ion channel and inhibits voltage-gated sodium currents.2,3 Long-term data of cenobamate has been studied in the open-label extensions of the double-blind placebo control trials as well as the open-label safety study in adults with uncontrolled partial-onset seizures. Additionally, cenobamate is being assessed in an ongoing randomized, double-blind, placebo-controlled trial evaluating its safety and efficacy as adjunctive therapy in patients with primary generalized tonic-clonic seizures (NCT03678753).7
Cenobamate was discovered by
IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI (cenobamate tablets) CV can be found on www.xcopri.com.
About
Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.
References
1. https://www.clinicaltrials.gov/ct2/show/NCT01397968
2. https://www.clinicaltrials.gov/ct2/show/NCT01866111
3. https://www.clinicaltrials.gov/ct2/show/NCT02535091
4. Guignet M, Campbell A, White HS, Epilepsia. 2020 Oct 16. doi: 10.1111/epi.16718. Online ahead of print
5. Nakamura M, et al. Eur J Pharmacol 2019;855:175-182.
6. Sharma R, et al. Eur J Pharmacol 2020;879:173117.
7. https://www.clinicaltrials.gov/ct2/show/NCT03678753
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