Alprazolam safe, effective for controlling seizures

The use of alprazolam leads to rapid termination of seizures in patients with focal and/or generalized epilepsy treated in an inpatient setting, according to the results of the phase II study ENGAGE-E-001.

ENGAGE-E-001 screened 273 patients with stereotypic seizure episodes with prolonged or repetitive seizures. Of the patients, 116 were included and randomized to double-blind treatment of a single seizure event with one dose of alprazolam at 1.0 mg (n=38) or 2.0 mg (n=38) or placebo (n=40) in an inpatient unit. Treatment was administered via Staccato, a breath-actuated device that delivers the drug deep into the lungs for rapid systemic exposure.

Treatment response, the primary endpoint, was defined as seizure activity cessation within 2 minutes following administration of study drug with no recurrence of seizure activity over 2 hours.

Response was documented in 65.8 percent of patients in both the 1.0- and 2.0-mg alprazolam groups as opposed to 42.5 percent in the placebo group (p=0.0392 and p=0.0392, respectively).

In terms of safety, alprazolam administered as a single dose of either 1.0 mg or 2.0 mg was tolerated well. The most common adverse events (AEs) were cough (14.5 percent), somnolence (14.5 percent), and dysgeusia (13.2 percent). Most of these events were mild or moderate in intensity.

None of the patients experienced treatment-related serious AEs.

In light of the present data, a phase III trial will be conducted to assess the efficacy and safety of Staccato-administered alprazolam for rapid cessation of seizures in an outpatient setting.