A Pilot Study Assessing the Bioavailability and Pharmacokinetics of Diazepam After Intranasal and Intravenous Administration in Healthy Volunteers

Diazepam rectal gel (Diastat®) is the only FDA-approved product indicated for acute repetitive seizures. Despite its proven efficacy, most older children and adults object to this route of administration. As a result, many patients do not realize the benefit of a therapy that can improve outcomes and decrease healthcare costs. Intranasal administration of benzodiazepines offers … Continued

Bioavailability of Intranasal vs. Rectal Diazepam

There remains an unmet medical need in the out-of-hospital management of seizure emergencies because older children and adults often refuse treatment with rectal gel due to social objections. We have previously reported that intranasal diazepam (DZP) administration is feasible, with maximum plasma concentrations (Cmax) and time to maximum concentration (Tmax) that are comparable to rectal DZP; but tolerability was poor. In … Continued

Bioavailability and Tolerability of Intranasal Diazepam in Healthy Adult Volunteers

Intranasal therapy has been proposed as an alternative for the management of seizure emergencies. The bioavailability, dose proportionality and tolerability of a supersaturated intranasal formulation of diazepam (DZP) solubilized in a glycofurol-water cosolvent system was investigated. Eight healthy volunteers were randomized into a single-blind, three-way crossover study to compare 5 and 10mg intranasal DZP doses … Continued

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