Novel Intranasal Spray Treats Epilepsy Seizures in Early-stage Trial

An intranasal midazolam spray designed to treat seizures in epilepsy patients yielded favorable results in an early trial, according to data presented at the 66th Annual American Academy of Neurology (AAN) meeting, held April 26, 2014, to May 3, 2014, in Philadelphia.

Developed by Upsher-Smith Laboratories, the investigational drug USL261 is intended to relieve sporadic and unexpected seizures clusters acute seizures. As the spray is delivered intranasally, it does not require the patient’s active inhalation.

For the phase 1 trial, USL261 was administered in 2.5 mg, 5.0 mg, or 7.5 mg doses of intranasal midazolam to 90 epilepsy patients aged 12-65 years who were taking other antiepileptic drugs (AEDs). The investigators compared the patients’ psychomotor performance before and after treatment.

In as early as 10 minutes following administration, the researchers noted a change in pharmacodynamic effects and psychomotor performance. Additionally, sedation and psychomotor performance scores normalized 4 hours after the drug was taken.

By taking blood samples before and after dosing, the investigators observed the change in plasma concentrations associated with the drug and discovered a dose up to 7.5 mg was absorbed rapidly and had a short half-life.

"Adverse effects appeared modest and were consistent with known benzodiazepine adverse effects,” study contributor James Cloyd, PharmD, said in a statement. “Findings presented at AAN support the continued development of USL261 for outpatient rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity.”