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Consistent safety and tolerability of Valtoco® (diazepam nasal spray) in relationship to usage frequency in patients with seizure clusters: Interim results from a phase 3, long-term, open-label, repeat-dose safety study.

Ian MillerJames W WhelessRobert Edward HoganDennis DlugosVictor BitonGregory D CascinoMickael R SperlingKore LiowBlanca VazquezEric B SegalDaniel TarquinioWeldon MauneyJay DesaiAdrian L RabinowiczEnrique Carrazananull null
Published in: Epilepsia open (2021)
Frequency of dosing diazepam nasal spray had little impact on the safety/tolerability profile across a range of <2 to >5 doses/month. Effectiveness was suggested for all dosing frequencies by the high proportion of seizure clusters not treated with a second dose. These results support the utility, safety profile, and effectiveness of diazepam nasal spray across frequencies of seizure cluster burden.
Keyphrases
  • open label
  • randomized controlled trial
  • systematic review
  • study protocol
  • squamous cell carcinoma
  • newly diagnosed