Upsher Smith presented positive Phase 1 data for its USL261 intranasal midazolam at the American Academy of Neurology (AAN) Meeting this week. The company launched a website to recruit patients for a Phase 3 study of the product last year.
The intranasal formulation is being developed for the rescue treatment of seizures in epilepsy patients and is “intended to be administered by a caregiver without active inhalation by the patient.”
According to Upsher Smith, the data show that midazolam plasma concentrations reached maximum levels within 10-15 min after dosing with USL261, and USL261 showed improved absorption and bioavailability compared to intranasally delivered injectable midazolam. Doses of up to 7.5 mg were “generally well tolerated.”
University of Wisconsin Professor of Pharmacy and Neurology/Division Chair Barry Gidal commented, “The data presented at AAN from the development program for USL261 support the safety profile and favorable pharmacokinetics/pharmacodynamics of USL261 in healthy volunteers. These findings support the further development of USL261 for seizure rescue in patients with intermittent bouts of increased seizure activity, a population for which few treatment options are currently available.”
Read the Upsher Smith press release.
