Riluzole pharmacokinetics in young patients with spinal muscular atrophy

  • Abbara C
  • Estournet B
  • Lacomblez L
 et al. 
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Abstract

Aims: The objective of the present study was to assess the pharmacokinetics of riluzole in patients with spinal muscular atrophy (SMA). Methods: Fourteen patients were enrolled in an open-label, nonrandomized and repeat-dose pharmacokinetic study. All participants were assigned to receive 50mg riluzole orally for 5 days. Riluzole plasma concentrations were determined from samples obtained at day 5. Results: The pharmacokinetic analysis demonstrated that a dose of 50mg once a day was sufficient to obtain a daily total exposure [AUC(0,24h)=2257ngml -1h] which was comparable with results obtained in adult healthy volunteers or ALS patients in whom a dose of 50mg twice a day is recommended. The pharmacokinetic simulation demonstrated that the administration of 50mg twice a day could result in higher concentrations, hence reduced safety margin. CONCLUSION The dose of 50mg once a day was chosen for the clinical trial evaluating the efficacy of riluzole in SMA patients. ? 2011 The Authors. British Journal of Clinical Pharmacology ? 2011 The British Pharmacological Society.

Author-supplied keywords

  • [Pharmacokinetics, Riluzole, Spinal muscular atrop

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Authors

  • C. Abbara

  • B. Estournet

  • L. Lacomblez

  • B. Leli?vre

  • A. Ouslimani

  • B. Lehmann

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