> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Extrapolating Partial Onset Seizure Drug Data
- URL: https://www.fdaweb.com/extrapolating-partial-onset-seizure-drug-data/
- Published: 2024-07-15T12:00:00.000Z
- Updated: 2026-09-14T14:35:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157345

FDA has released a guidance entitled “Drugs for Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients One Month of Age and Older.” The [document](https://www.fda.gov/medical-devices/medical-device-recalls/ventilator-recall-baxter-removes-life2000-ventilator-due-potential-failure-battery-charging-dongle?utm%5Fmedium=email&utm%5Fsource=govdelivery) provides recommendations to sponsors on the clinical development of drugs for the treating partial onset seizures (POS) in pediatric patients. Specifically, it addresses programs that can support extrapolation of the efficacy of drugs approved for treating POS in adults to pediatric patients one month of age and older.

FDA says efficacy can be extrapolated when it is reasonable to assume that children have a similar disease progression of disease, similar treatment responses, and similar exposure-response relationships to adults. “After excluding children with POS associated with epileptic encephalopathies, such as Lennox-Gastaut syndrome, the pathophysiology of POS appears similar in adults and pediatric patients one month of age and older,” the guidance says. “Clinical studies of drugs for treating POS in pediatric patients, some of which enrolled patients as young as one month of age, have shown a response to treatment (reduction in seizure frequency) similar to the response to treatment seen in adults. Initial systematic and quantitative analyses conducted by FDA, using data from clinical studies of drugs with a variety of putative mechanisms of action approved for the treatment of POS in both adults and pediatric patients, have shown that the relationship between exposure and response (reduction in seizure frequency) is similar in adults and pediatric patients four years of age and older.”