Rimegepant Dose Selection for Pediatric Patients With Migraine

A new population pharmacokinetic model for oral rimegepant has been developed and used to predict exposure in a virtual pediatric population generated using United States national growth charts. The study's results suggest that exposure with rimegepant 75 mg orally disintegrating tablet was evaluated in simulated participants aged 6 to 17 years, and exposure with rimegepant 25, 35, 50, and 75 mg was evaluated in simulated participants weighing 9 to 75 kg. The recommended single and every-other-day doses of rimegepant orally disintegrating tablet in the pediatric population were 75 mg in adolescents 12 to 40 kg, 50 mg in children 6 to 25 to 40 kg, and 35 mg in children 6 to 15 to 25 kg.

Key Takeaways:

• A new population pharmacokinetic model for oral rimegepant was developed and updated with data from pediatric and adult studies, predicting rimegepant exposure in a virtual pediatric population.
• The study evaluated exposure with rimegepant 75 mg orally disintegrating tablet in simulated participants aged 6 to 17 years and with rimegepant 25, 35, 50, and 75 mg in simulated participants weighing 9 to 75 kg.
• The recommended single and every-other-day doses of rimegepant orally disintegrating tablet in the pediatric population were 75 mg in adolescents 12 to 40 kg, 50 mg in children 6 to 25 to 40 kg, and 35 mg in children 6 to 15 to 25 kg.
• The study's results support further evaluation of rimegepant efficacy and safety in pediatric patients with migraine.
• Rimegepant exposure was evaluated in a virtual pediatric population generated using United States national growth charts.
• The study's population pharmacokinetic model was used to predict exposure in a virtual pediatric population.

Statistics:

• 11 phase I studies in adults were used to develop the initial population pharmacokinetic model.
• 20 pediatric and 74 adult participants were included in the updated population pharmacokinetic model.
• 1000 simulations were conducted for each age group (6-17 years) and weight group (9-75 kg) to evaluate exposure with rimegepant 75 mg orally disintegrating tablet.
• The recommended doses of rimegepant orally disintegrating tablet in the pediatric population were 75 mg, 50 mg, and 35 mg for adolescents, children 6-25 to 40 kg, and children 6-15 to 25 kg, respectively.

Sources:

• Exposure Matching Using Population Pharmacokinetic Modeling and Simulation to Support Rimegepant Dose Selection for Pediatric Patients With Migraine. Clinical and Translational Science, 2025;18(10).
• Wiley, 111 River St, Hoboken 07030-5774, NJ, USA.
• Pfizer Inc.
• United States national growth charts.