Sumatriptan Iontophoretic Transdermal System in Adolescent Migraine Patients
Since nausea can be a notable symptom of migraine, non-oral treatment options are often essential. In adults, sumatriptan iontophoretic TDS is approved for the acute treatment of migraine. A study has estimated the pharmacokinetics of sumatriptan. It was performed to evaluate the safety, tolerability, and pharmacokinetics of sumatriptan delivered by the iontophoretic transdermal system (TDS) in adolescent patients.
Patients aged 12–17 years with acute migraine were managed with sumatriptan iontophoretic TDS for 4 hours. Blood samples for pharmacokinetic profiling of sumatriptan were acquired prior to dosing and at predetermined time points covering 12 hours post onset of treatment. Key pharmacokinetic endpoints were: Cmax (peak plasma drug concentration), tmax (time to Cmax), AUC0–∞ (area under plasma concentration–time curve from time 0 to infinity), and t½ (terminal elimination half-life). Safety was examined by monitoring of adverse events, laboratory and clinical assessments.
The sample comprised of 37 patients, and 36 were included in the PK evaluable population. Between male and female- younger (12–14 years) and older (15–17 years) adolescents, values were similar for Cmax, tmax, AUC0–∞, and t½. When compared with historical adult data, adolescent patients exhibited similar systemic exposures to those observed in adults (mean Cmax 20.20 (±6.43) ng/mL in adolescent vs 21.89 (±6.15) ng/mL in adults; mean AUC0–∞ 98.1 (±28.1) ng·h/mL in adolescent vs 109.7 (±26.1) ng·h/mL in adults). Mild or moderate adverse events were observed with application-site paresthesia being the most common (32%). There were no clinically relevant changes in laboratory values, vital signs, or electrocardiogram findings.
The culmination of this study led to the finding that iontophoretic TDS produced mean systemic exposures to sumatriptan in younger and older adolescents, in line with what was seen in adult subjects which was generally well-tolerated.