Pharmacokinetics of frovatriptan in adolescent migraineurs.

Frovatriptan is a selective 5-HT(1B/1D) receptor agonist available for acute treatment of migraine in adults (18 years and older). The objective of this study was to determine key pharmacokinetic parameters of frovatriptan in adolescent migraineurs after a single 2.5-mg oral dose and to compare these results with those from an earlier study completed in adults. Subjects were stratified by age (12-14 and 15-17 years) and gender, and serial blood and urine samples were collected over 48 hours. A total of 25 subjects (13 male, 12 female) completed the study. Pharmacokinetic profiles for adolescent subjects were similar to those observed in adults. The median tmax ranged from 2 (male subjects) to 3 (female subjects) hours. The AUC0-24h and Cmax were slightly lower in adolescent subjects as compared with adults. As seen in adults, AUC0-24h and Cmax values were approximately 2-fold higher in females than in their male counterparts (AUC mean range 40.5-59.8 ng x h/mL vs 21.2-23.5 ng x h/mL and Cmax mean range 4.02-6.14 vs ng x h/mL 2.52-2.99 ng/mL, in female and male adolescent subjects, respectively). Elimination was biphasic, with an approximate terminal elimination half-life (t(1/2)) between 12.2 and 25.5 hours. Renal clearance was similar in adolescents and adults, being somewhat higher in female than male subjects. Frovatriptan was well tolerated with no serious or treatment-related adverse effects. In addition, there were no clinically significant changes in safety parameters. Overall, the pharmacokinetic profile of frovatriptan in adolescents (12-17 years) is similar to that seen in adults, and dosing adjustments are unlikely to be needed. Copyright 2004 American College of Clinical Pharmacology