Lack of observed impact of history or concomitant treatment of seasonal allergies or rhinitis on repeated doses of diazepam nasal spray administered per seizure episode in a day, safety, and tolerability: Interim results from a phase 3, open-label, 12-month repeat-dose safety study
| Autor: | James W. Wheless, Enrique Carrazana, Adrian L. Rabinowicz, Jay Desai, Blanca Vazquez |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Allergy
medicine.medical_treatment 03 medical and health sciences Behavioral Neuroscience Epilepsy 0302 clinical medicine Double-Blind Method Seizures medicine Humans 030212 general & internal medicine Child Administration Intranasal Rhinitis Diazepam business.industry Nasal Sprays medicine.disease Regimen Nasal Absorption Treatment Outcome Neurology Tolerability Nasal spray Anesthesia Nasal administration Seasons Neurology (clinical) business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Epilepsy & Behavior. 118:107898 |
| ISSN: | 1525-5050 |
| Popis: | Intranasal formulations are commonly used for drug delivery, and the literature has shown that seasonal allergies do not affect nasal administration of some agents. Diazepam nasal spray (Valtoco®) is a proprietary intranasal formulation with n-dodecyl-beta- d -maltoside (Intravail® A3) that is indicated for acute treatment of seizure clusters in patients with epilepsy aged 6 years and older. The analysis presented here is from an interim cutoff of a phase 3 open-label study evaluating the safety and tolerability of diazepam nasal spray. This analysis assessed whether seasonal allergies alter control of seizures with an intranasal formulation, using administration of a second dose as a surrogate efficacy endpoint. Of 158 evaluated patients with epilepsy having seizures despite a stable anti-seizure regimen, 62 patients had medical histories that included seasonal allergies or rhinitis. The results of this analysis show that seasonal allergies did not appear to influence use of a second dose; the groups of patients with and without a history of seasonal allergies both presented with low rates of seizure episodes for which a second dose was used, which suggests that there is not a major difference in pattern of use. Diazepam nasal spray demonstrated a similar safety and tolerability profile in patients with and without a history of seasonal allergies. |
| Databáze: | OpenAIRE |
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