In people suffering from uncontrolled focal seizures, the consistently high retention rates of cenobamate therapy revealed it to be an efficacious and well-tolerated novel treatment choice for the management of seizures. In this study, the researchers revealed pooled exposure, safety data, and retention rates from a large population with seizure that was given open-label adjunctive cenobamate therapy in the clinical development program.

Pooling of data was done from 2 randomized, controlled cenobamate studies and 1 open-label pharmacokinetic and safety study. Considering the percentage of people remaining on therapy, an estimation of retention rates was done with the aid of Kaplan-Meier survival analyses. The researchers carried out 2 additional assessments for exploring the factors contributing to retention.

A robust data set (through two years) was stratified by cenobamate modal dose and the frequently utilized concomitant anti-seizure medicines. Treatment-emergent noxious events and cenobamate discontinuations were enumerated. Data from 1844 people were pooled: (i) 355 from a multi-dose randomized trial, (ii) 149 from a single-dose randomized trial, and (iii) 1340 from an open-label pharmacokinetic and safety study.

The majority of the people from randomized trials continued in open-label extensions. The pooled data represented >95% of people exposed to cenobamate therapy. The baseline characteristics and disease and therapy histories were similar across studies. The median duration of cenobamate exposure was thirty-four months, with a median modal dose of 200 mg/day.

The Kaplan-Meier estimates of cumulative cenobamate retention rates at one year and two years is shown in Table 1:

Once the recruited people achieved the maintenance phase, the retention rates were consistently high in people receiving ≥100 mg/day cenobamate. The concomitant anti-seizure medicines did not impact long-term retention. Notably, 535 (29%) had actually discontinued cenobamate by two years.

Withdrawal of consent (21.1%), adverse events (37.6%), and others (16.8%) were the most commonly noted reasons for cenobamate discontinuation. Thus, the treatment retention rates offered real-world, practical evidence for long-term safety, effectiveness, adherence, and tolerability.