USL261: Phase I data

A crossover Phase I trial in 25 healthy volunteers showed that single doses of 2.5, 5 and 7.5 mg intranasal USL261 were generally well tolerated and did not result in excessive or prolonged sedation or psychomotor impairment. The most common treatment-related adverse events reported were dysgeusia, increased lacrimation, nasal discomfort and throat irritation. Upsher-Smith said that maximum plasma concentrations of midazolam were achieved within 15-20 minutes of dosing and that USL261 showed increased absorption with improved bioavailability compared to an equivalent dose of injectable midazolam delivered intranasally. Data were presented at the American Academy of Neurology meeting in San Diego. ...