Staccato Alprazolam Shows efficacy and Tolerability for rapid termination of seizures in Phase 1 Studies

The key findings of the study were as follows:

• Rapid Absorption: Alprazolam was rapidly absorbed, with a median time to peak plasma concentration (Tmax) of 1.5–2 minutes post-dose in both studies.

• This rapid absorption was consistent across smokers, nonsmokers, and participants of different ethnicities.

• Similar Absorption in Smokers and Nonsmokers: Staccato alprazolam was absorbed to a similar extent in both smokers and nonsmokers, indicating consistent pharmacokinetics regardless of smoking status.

• Tolerability: The most commonly reported treatment-emergent adverse events (TEAEs) were somnolence and dizziness, with no serious or severe TEAEs reported.

• Staccato alprazolam demonstrated a safety profile consistent with other alprazolam formulations, with no new safety signals identified.

The phase 1 studies of Staccato alprazolam demonstrated rapid absorption, reaching therapeutic drug levels within 2 minutes post-dose. The drug was well tolerated across different populations, including smokers and individuals of various ethnicities. These findings support further investigation of Staccato alprazolam as a potential treatment for rapid seizure termination.

Reference:

Hayakawa, Y., Rospo, C., Bartmann, A. P., King, A., Roebling, R., & Chanteux, H. (2024). Pharmacokinetics of Staccato® alprazolam in healthy adult participants in two phase 1 studies: An open‐label smoker study and a randomized, placebo‐controlled ethnobridging study. Epilepsia. https://doi.org/10.1111/epi.17901