TABLE 2.
Safety summary (safety population)
| n (%) | Open‐label | Double‐blind | |||
|---|---|---|---|---|---|
| 1.0 mg Staccato alprazolam (n = 8) | Staccato alprazolam | ||||
| Staccato placebo (n = 40) | 1.0 mg (n = 38) | 2.0 mg (n = 38) | Combined active group (n = 76) | ||
| Total number of AEs | 5 | 20 | 35 | 39 | 74 |
| Patients with at least one AE | 3 (37.5) | 12 (30.0) | 14 (36.8) | 19 (50.0) | 33 (43.4) |
| Serious AEs | 0 | 2 (5.0) | 1 (2.6) | 0 | 1 (1.3) |
| Severe AEs | 1 (12.5) | 3 (7.5) | 1 (2.6) | 0 | 1 (1.3) |
| Drug‐related | 1 (12.5) | 3 (7.5) | 8 (21.1) | 15 (39.5) | 23 (30.3) |
| Resulting in using concomitant medication | 1 (12.5) | 4 (10.0) | 3 (7.9) | 2 (5.3) | 5 (6.6) |
| Discontinuation due to AEs | 0 | 0 | 0 | 0 | 0 |
| AEs occurring in ≥5% of patients in any treatment group | |||||
| Cough | 1 (12.5) | 0 | 4 (10.5) | 7 (18.4) | 11 (14.5) |
| Somnolence | 0 | 1 (2.5) | 7 (18.4) | 4 (10.5) | 11 (14.5) |
| Dysgeusia | 0 | 1 (2.5) | 6 (15.8) | 4 (10.5) | 10 (13.2) |
| Dizziness | 0 | 2 (5.0) | 2 (5.3) | 2 (5.3) | 4 (5.3) |
| Nausea | 0 | 1 (2.5) | 1 (2.6) | 2 (5.3) | 3 (3.9) |
| Sedation | 0 | 0 | 0 | 2 (5.3) | 2 (2.6) |
| Throat irritation | 1 (12.5) | 0 | 0 | 2 (5.3) | 2 (2.6) |
| Headache | 0 | 2 (5.0) | 1 (2.6) | 0 | 1 (1.3) |
| Fatigue | 0 | 2 (5.0) | 0 | 0 | 0 |
| Musculoskeletal chest pain | 1 (12.5) | 0 | 0 | 0 | 0 |
| Gastroenteritis viral | 1 (12.5) | 0 | 0 | 0 | 0 |
| Dysmenorrhea | 1 (12.5) | 0 | 0 | 0 | 0 |
Abbreviation: AE, adverse event.