New intranasal epilepsy treatment shows promise in early trial
A new study has demonstrated the potential benefits of a promising new intranasal treatment for epilepsy.
Developed by Upsher-Smith Laboratories, the investigational intranasal midazolam therapy – known under the developmental name USL261 – has been assessed in a phase I clinical study involving 90 patients with epilepsy between the ages of 12 and 65.
USL261 is an investigational formulation of midazolam intended for rescue treatment in patients who require control of intermittent bouts of increased seizure activity, including seizure clusters or acute repetitive seizures.
Each of the subjects were on stable antiepileptic drug regimens prior to treatment with midazolam, which was administered in a single dose of 2.5 mg, 5.0 mg or 7.5 mg by unit-dose nasal-spray.
According to results presented at the Annual American Academy of Neurology (AAN) annual meeting, USL261 therapy at a single dose of up to 7.5 mg was rapidly absorbed and exhibited a short half-life, as well as being generally well-tolerated.
A rapid onset of pharmacodynamic effects was observed within ten minutes following administration, returning to baseline function four hours after dosage.
The promising nature of the new treatment means it has earned orphan drug designation from the US Food and Drug Administration. This classification is granted to treatments that serve an unmet clinical need, or represent a significant advance over currently-available options.
At present, the only approved out-of-hospital treatment for bouts of increased seizures is rectal diazepam.
Dr James Cloyd, a professor at the department of experimental and clinical pharmacology at the University of Minnesota College of Pharmacy, said: “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.”
There are already a number of midazolam-based treatments available for use among epilepsy patients affected by prolonged acute convulsive seizures, including the injectable therapy Buccolam, also known as buccal midazolam.
Posted by Anne Brown