Clinical Trials

Inclusion Criteria:

- Participant must be ≥12 years of age at the time of signing informed consent

- Participant must have a study caregiver ≥18 years of age at the time of signing the
informed consent; the study caregiver(s) must be able to recognize and observe the
participant's seizures

- Participants with an established diagnosis of focal or generalized epilepsy or
combined focal and generalized epilepsy with a documented history of stereotypical
episodes of prolonged seizures that includes at least 1 of the following:

1. Generalized seizure episodes starting with a flurry of absence seizures or
myoclonic seizures with a minimum total duration of 5 minutes

2. Episodes of a focal seizure with a minimum duration of 3 minutes

3. Episodes of a focal seizure or a flurry of myoclonic seizures for at least 90
seconds followed by a generalized/bilateral tonic-clonic seizure with a minimum
total duration of 3 minutes

- Prior to the Screening Visit, participant completed a study using Staccato alprazolam

Exclusion Criteria:

- Participant has a current history of alcohol or drug use disorder, as defined in the
Diagnostic and Statistical Manual of Mental Disorders 5, within the previous 1 year

- Participant has a known hypersensitivity to any components of the investigational
medicinal product (IMP) or comparable drugs (and/or an investigational device) as
stated in this protocol or to albuterol (or similar bronchospasm rescue medication if
needed to meet country-specific requirements)

- Participant has a history of convulsive status epilepticus in the 8 weeks prior to the
Screening Visit

- Participant has a history or presence of known nonepileptic seizures which cannot be
distinguished from qualifying epileptic seizures

- Participant has a clinically significant known airway hypersensitivity and/or acute
respiratory signs/symptoms

- Participant has a clinically significant chronic pulmonary disorder and/or recent
history or presence of hemoptysis or pneumothorax

- Participant has ever been diagnosed with asthma (irrespective of current treatment)

- Participant has had a positive antigen test for severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) and experienced moderate to severe signs/symptoms of
respiratory distress necessitating hospitalization or outpatient treatment such as
ambulatory oxygen, extensive treatment with inhaler medications, and/or oral
medications for a duration of 4 weeks or more, unless full resolution occurred at
least 6 months prior to Screening

- Participant has experienced a severe upper respiratory tract infection within 4 weeks
or severe bronchitis/pneumonia within 3 months before the Screening Visit

- Participant has a history or presence of acute narrow-angle glaucoma

- Participant has a condition for which oral alprazolam is contraindicated

- Participant is taking any drug that is a strong CYP3A4 inhibitor, including azole
antifungal agents (ketoconazole and itraconazole) and nefazodone

- Participant is taking any opioids or sedative hypnotics on a chronic basis

- Participant is taking nonselective beta blockers on a chronic basis

- Participant has a forced expiratory volume in 1 second (FEV1) <80 % of (FEV1) as
measured via spirometry at the Screening Visit