Methods and compositions for treating seizure disorders in pediatric patients
AssigneeNeurelis, Inc.
InventorsAdrian L. Rabinowicz, Enrique J. Carrazana
Life of this patent
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Abstract
Compositions for intranasal delivery of benzodiazepines, such as diazepam, midazolam, and lorazepam and methods for their use to treat and prevent seizures in pediatric subjects aged 2-5, inclusive. Compositions for rapid therapeutic onset with a decreased incidence and/or severity of adverse effects after administration and methods of improving patient compliance with a prescribed treatment regimen.
Claims33
A method of treating intermittent, stereotypic episodes of frequent seizure activity that are distinct from a subject's usual seizure pattern in a pediatric subject that is 2 to 5 years old and 23 to 33 kg in body weight having epilepsy, said method comprising:
- intranasally administering a pharmaceutical solution to the pediatric subject, wherein the pharmaceutical solution is one spray in each nostril of 100 μL of pharmaceutical solution having a diazepam concentration of 75 mg/mL, 0.25% w/v dodecyl maltoside, and a carrier system comprising 10.5% w/v benzyl alcohol;
- wherein said administering is to a nasal mucosal membrane of the pediatric subject to treat the intermittent, stereotypic episodes of frequent seizure activity that are distinct from the subject's usual seizure pattern in the pediatric subject.
A method of treating intermittent, stereotypic episodes of frequent seizure activity that are distinct from a subject's usual seizure pattern in a pediatric subject that is 2 to 5 years old and 6 to 11 kg in body weight having epilepsy, said method comprising:
- intranasally administering a pharmaceutical solution to the pediatric subject, wherein the pharmaceutical solution is one spray in a single nostril of 100 μL of the pharmaceutical solution having a diazepam concentration of 50 mg/mL, 0.25% w/v dodecyl maltoside and a carrier system comprising 10.5% w/v benzyl alcohol;
- wherein said administering is to a nasal mucosal membrane of the pediatric subject to treat the intermittent, stereotypic episodes of frequent seizure activity that are distinct from the subject's usual seizure pattern in the pediatric subject.
A method of treating intermittent, stereotypic episodes of frequent seizure activity that are distinct from a subject's usual seizure pattern in a pediatric subject that is 2 to 5 years old and 12 to 22 kg in body weight having epilepsy, said method comprising:
- intranasally administering a pharmaceutical solution to the pediatric subject, wherein the pharmaceutical solution one spray in a single nostril of 100 μL of the pharmaceutical solution having a diazepam concentration of 100 mg/mL, 0.25% w/v dodecyl maltoside and a carrier system comprising 10.5% w/v benzyl alcohol;
- and
- wherein said administering is to a nasal mucosal membrane of the pediatric subject to treat the intermittent, stereotypic episodes of frequent seizure activity that are distinct from the subject's usual seizure pattern in the pediatric subject.
Dependencies are inferred from the claim text.