Upsher-Smith Laboratories has presented data from a Phase 1 study of its USL261 midazolam nasal spray in children with epilepsy demonstrating that the median Tmax for 1.25 mg, 2.5 mg and 5 mg single doses was ~15 minutes and Cmax was not dose dependent.
According to the company, the FDA has granted both fast track and orphan drug designations to USL261 for rescue treatment of patients with intermittent increases in the number of seizures they experience.
Upsher-Smith Chief Scientific Officer and Biotech Research Institute Division President William Pullman commented, “Upsher-Smith is pleased to debut these Phase I clinical trial results at this year’s Child Neurology Society meeting. Pediatric patients and their caregivers currently have few options for treating bouts of increased seizure activity. This study of intranasal midazolam, in patients from ages two to 13 years with epilepsy, showed a desirable pharmacokinetic profile, which supports the continued development of USL261 in this important patient population.”
Read the Upsher-Smith press release.
