TABLE 5.
TEAEs in study 2 a
| TEAE, number (%) of participants |
Treatment F LXB (n = 47) |
Treatment G SXB (n = 47) |
Treatment H LXB (n = 46) |
Treatment I SXB (n = 46) |
Treatment J SXB (n = 47) |
Treatment K LXB (n = 47) |
|---|---|---|---|---|---|---|
| 60 ml water, fasted | 60 ml water, fed | 240 ml water, fasted | ||||
| Any TEAE | 44 (93.6) | 46 (97.9) | 40 (87.0) | 41 (89.1) | 45 (95.7) | 45 (95.7) |
| TEAEs in ≥10% participants in any group | ||||||
| Somnolence | 39 (83.0) | 41 (87.2) | 34 (73.9) | 33 (71.7) | 38 (80.9) | 37 (78.7) |
| Dizziness | 22 (46.8) | 23 (48.9) | 21 (45.7) | 18 (39.1) | 24 (51.1) | 19 (40.4) |
| Nausea | 13 (27.7) | 21 (44.7) | 5 (10.9) | 3 (6.5) | 16 (34.0) | 16 (34.0) |
| Headache | 9 (19.1) | 10 (21.3) | 7 (15.2) | 10 (21.7) | 6 (12.8) | 10 (21.3) |
| Fatigue | 5 (10.6) | 5 (10.6) | 4 (8.7) | 3 (6.5) | 1 (2.1) | 2 (4.3) |
| Paresthesia | 5 (10.6) | 11 (23.4) | 6 (13.0) | 5 (10.9) | 5 (10.6) | 3 (6.4) |
| Vertigo | 4 (8.5) | 8 (17.0) | 2 (4.3) | 3 (6.5) | 6 (12.8) | 5 (10.6) |
| Euphoric mood | 6 (12.8) | 2 (4.3) | 3 (6.5) | 2 (4.3) | 1 (2.1) | 1 (2.1) |
| Abdominal pain | 3 (6.4) | 5 (10.6) | 2 (4.3) | 0 | 1 (2.1) | 2 (4.3) |
| Vision blurred | 3 (6.4) | 5 (10.6) | 0 | 0 | 3 (6.4) | 3 (6.4) |
Abbreviations: LXB, lower‐sodium oxybate; SXB, sodium oxybate; TEAE, treatment‐emergent adverse event.
a
F: LXB 4.5 g fasted, 60 ml water; G: SXB 4.5 fasted, 60 ml water; H: LXB 4.5 g fed, 60 ml water; I: SXB 4.5 g fed, 60 ml water; J: SXB 4.5 g fasted, 240 ml water; K: LXB 4.5 g fasted, 240 ml water.