Alprazolam delivered by Staccato device effective for rapid control of seizures

The key findings of this study were:

1.In the double-blind portion, 273 individuals were screened, and 116 randomized participants got therapy with the study medication.

2.The proportion of treated patients who responded to Staccato alprazolam 1.0 mg (n = 38; p =.0392) and 2.0 mg (n = 38; p =.0392) was 65.8%, compared to 42.5% for Staccato placebo (n = 40).

3.When delivered as a single dosage of 1.0 or 2.0 mg, staccato alprazolam was well tolerated: cough and somnolence were the most prevalent adverse effects (AEs) (both 14.5%), followed by dysgeusia (13.2%).

4.The majority of the adverse events (AEs) were mild to moderate in severity; there were no treatment-related significant AEs.

In conclusion, this proof-of-concept research found that 1.0 mg and 2.0 mg dosages of Staccato alprazolam were both effective and well tolerated in promptly ending seizures in a limited observed group in an inpatient environment. The next step will be a larger Phase 3 outpatient confirmatory research to show the effectiveness and safety of Staccato alprazolam for quick seizure cessation in an outpatient environment among patients 12 years of age and older with stereotyped protracted seizures.

Reference:

French, J., Biton, V., Dave, H., Detyniecki, K., Gelfand, M. A., Gong, H., Liow, K., O'Brien, T. J., Sadek, A., DiVentura, B., Reich, B., & Isojarvi, J. (2022). A randomized phase 2b efficacy study in patients with seizure episodes with a predictable pattern using Staccato® alprazolam for rapid seizure termination. In Epilepsia. Wiley. https://doi.org/10.1111/epi.17441