A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Inclusion Criteria:

• Participant must be ≥12 years of age at the Baseline/Randomization Visit

• Participant must have a study caregiver ≥18 years of age at the Screening Visit; thestudy caregiver(s) must be a relative, partner, friend, or legally authorizedrepresentative (LAR) of the participant, or a person who provides daily care to theparticipant and has a significant personal relationship with the participant; thestudy caregiver(s) must be able to recognize and observe the participant's seizures

• Participants with an established diagnosis of focal or generalized epilepsy orcombined focal and generalized epilepsy with a documented history of stereotypicalepisodes of prolonged seizures that includes at least 1 of the following:

1. Generalized seizure episodes starting with a flurry of absence seizures ormyoclonic 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 90seconds followed by a generalized/bilateral tonic-clonic seizure with a minimumtotal duration of 3 minutes

• Prior to the Screening Visit, participant has experienced ≥4 stereotypical episodesof prolonged seizures in the past 6 months, and the last 2 stereotypical episodes ofprolonged seizures must have occurred within the 3 months prior to the ScreeningVisit

• Participant has had a documented brain computerized tomography or magnetic resonanceimaging review, performed after diagnosis of epilepsy and within the 5 years priorto the Screening Visit, that confirms the absence of a progressive neurologicaldisorder

• Participant is receiving a regimen of antiseizure medications (ASMs) that has beenstable (ie, no addition or removal of ASM[s]; dose adjustments are permitted toASM[s]; dose adjustments are not permitted for benzodiazepines) for 30 days prior tothe Screening Visit

• Male and female participants:

1. A male participant must agree to use contraception during the OutpatientTreatment Period and for at least 7 days after IMP administration and refrainfrom donating sperm during this period

2. A female participant is eligible to participate if she is not pregnant, notbreastfeeding, and at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to followthe contraceptive guidance during the Outpatient Treatment Period and for at least 30 days after IMP administration

• Participant is capable of giving signed informed consent (or giving assent, whererequired), which includes compliance with the requirements and restrictions listedin the informed consent form (ICF), the protocol, and the individualized participantmanagement plan (iPMP). The ICF or a specific assent form, where required, will besigned and dated by minors

• The participant's study caregiver(s) must be capable of giving signed informedconsent, which includes compliance with the requirements and restrictions listed inthe ICF, the protocol, and the iPMP

Exclusion Criteria:

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

• Participant has a known hypersensitivity to any components of the IMP or comparabledrugs (and/or an investigational device) as stated in this protocol or to albuterol (or similar bronchospasm rescue medication if needed to meet country-specificrequirements)

• Participant has a diagnosis of atrial fibrillation or mitral stenosis

• Participant has a history of convulsive (generalized tonic-clonic) statusepilepticus in the 8 weeks prior to the Screening Visit

• Participant has a history or presence of known nonepileptic seizures which cannot bedistinguished from qualifying epileptic seizures

• Participant has a clinically significant known airway hypersensitivity (eg,bronchospasm to known allergens, such as pollen, animals, or food) and/or acuterespiratory signs/symptoms (eg, shortness of breath, wheezing on lung auscultation)

• Participant has a clinically significant chronic pulmonary disorder other than mildasthma (eg, chronic obstructive pulmonary disease, restrictive lung diseases [including idiopathic pulmonary fibrosis]) and/or recent history or presence ofhemoptysis or pneumothorax

• Participant has had a positive antigen test for acute respiratory syndromecoronavirus 2 (SARS-CoV-2) and experienced moderate to severe signs/symptoms ofrespiratory distress necessitating hospitalization or outpatient treatment such asambulatory oxygen, extensive treatment with inhaler medications, and/or oralmedications for a duration of 4 weeks or more, unless full resolution occurred atleast 6 months prior to Screening

• Participant has experienced a upper respiratory tract infection within 4 weeks orbronchitis/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 (eg,myasthenia gravis, severe respiratory insufficiency, and sleep apnea syndrome)

• Participant has a history or presence of long QT syndrome, a family history ofsudden death due to long QT syndrome, or unexplained syncope

• Chronic use of benzodiazepines for more than 3 days within a period of 7 days willbe allowed for approximately 30 % of study participants

• Participant is taking any drug that is a strong CYP3A4 inhibitor, including azoleantifungal agents (ketoconazole and itraconazole) and nefazodone

• Participant is taking any opioids (eg, fentanyl, oxycodone, morphine) or sedativehypnotics on a chronic basis

• Participant is taking nonselective beta blockers on a chronic basis

• Participant is taking pharmacotherapy for an active major psychiatric disorder wheremajor changes in regimen are needed or anticipated during the study

• Participant has been treated with vagal nerve stimulation (VNS) for less than 6months or VNS settings have changed within 30 days before the Screening Visit

• Participant has a clinically significant laboratory abnormality that may increasethe risk associated with study participation or may interfere with theinterpretation of study results, according to the judgment of the Investigator

• Participant has an oxygen saturation <95 % (or less than normal in regions ofaltitude >2500 meters) for greater than 30 seconds during the Screening Visit. Incase of an out-of-range result, 1 repeat will be allowed. If the readings are out ofrange again, the study participant will be excluded

• Participant has >2.0x upper limit of normal (ULN) of any of the following: alanineaminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >1.0xULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert'ssyndrome or >2.0xULN total bilirubin for liver impairment)

• Participant has current unstable liver or biliary disease per Investigatorassessment defined by the presence of ascites, encephalopathy, coagulopathy,hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis

• Participant has a QT interval corrected for heart rate (QTc) >450 msec (males), QTcinterval >470 msec (females), or QTc interval >480 msec (participants with bundlebranch block), PR interval ≥220 msec, or any other clinically significantelectrocardiogram (ECG) abnormality according to the Investigator i) The QTc is theQT interval corrected for heart rate according to Fridericia's formula (QTcF). It iseither machine-read or manually over-read

• Participant has a positive urine screen for drugs of abuse at the Screening Visit

• Participant has a blood pressure (BP) or heart rate (HR) outside the following rangeafter 5 minutes rest: systolic BP: 90 mmHg to 150 mmHg; diastolic BP: 4 0mmHg to 95mmHg; HR: 50 bpm to 100 bpm. In case of an out-of-range result, 1 repeat will beallowed. If the readings are out of range again, the study participant will beexcluded