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Staccato alprazolam
Staccato alprazolam is a rapidly-absorbed inhaled formulation of alprazolam that binds to GABA-A receptors in the central nervous system to enhance inhibitory neurotransmission.
Staccato alprazolam is a rapidly-absorbed inhaled formulation of alprazolam that binds to GABA-A receptors in the central nervous system to enhance inhibitory neurotransmission. Used for Acute anxiety or panic episodes (Phase 3 development).
At a glance
| Generic name | Staccato alprazolam |
|---|---|
| Also known as | UCB7538, STAP-001 |
| Sponsor | UCB Biopharma SRL |
| Drug class | Benzodiazepine |
| Target | GABA-A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | Phase 3 |
Mechanism of action
Alprazolam is a benzodiazepine that potentiates the effect of the inhibitory neurotransmitter GABA by binding to GABA-A receptors, increasing chloride ion influx and hyperpolarizing neurons. The Staccato delivery system uses a proprietary pulmonary inhalation technology to achieve rapid systemic absorption through the lungs, enabling faster onset of action compared to oral formulations. This rapid onset is intended to provide faster symptom relief in acute anxiety or panic situations.
Approved indications
- Acute anxiety or panic episodes (Phase 3 development)
Common side effects
- Sedation
- Dizziness
- Headache
- Respiratory depression
- Dependence potential
Key clinical trials
- A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures (PHASE3)
- A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures (PHASE3)
- A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants (PHASE1)
- A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants (PHASE1)
- A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma (PHASE1)
- A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy (PHASE1)
- Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smokers Versus Non-Smokers (PHASE1)
- Staccato Alprazolam and Photoparoxysmal Response (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |