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Pharmacokinetics and safety of VALTOCO (NRL-1; diazepam nasal spray) in patients with epilepsy during seizure (ictal/peri-ictal) and nonseizure (interictal) conditions: A phase 1, open-label study.

Robert Edward HoganDaniel TarquinioMickael R SperlingPavel KleinIan MillerEric B SegalAdrian L RabinowiczEnrique Carrazana
Published in: Epilepsia (2020)
The epileptic conditions (ictal/peri-ictal, interictal) had minimal impact on diazepam nasal spray pharmacokinetics in patients with epilepsy. Therefore, diazepam nasal spray can be administered ictally and interictally. Diazepam nasal spray safety was consistent with the profile of diazepam.
Keyphrases
  • temporal lobe epilepsy
  • chronic rhinosinusitis
  • open label
  • clinical trial
  • randomized controlled trial
  • study protocol
  • locally advanced