Table 1.
Summary of key trials comparing intramuscular and intranasal epinephrine treatment
| Study | Study type | Population | Treatments | Cmax (pg/ml) | Tmax (min) | Main PD effects |
|---|---|---|---|---|---|---|
| Tanimoto et al. [40] | Four phase 1 crossover studies | 175 healthy adults | IM manual (0.3 mg), autoinjectors, IN spray (1 mg) | IN: 258 IM: 254 AUT: 438–503 |
IN: 30 IM: 30 AUT: 20 |
SBP increase (mean mmHg): IN: 16.9 IM: 10.9 AUT: 18.1 HR (mean beats/min): IN: 13.6 IM: 12.8 AUT: 14.4 |
| Casale et al. [41▪▪] | Phase 1, 6-treatment crossover study | 59 healthy adults | IN (2 mg) vs. IM vs. autoinjector | IN: 481 (mean) IM: 339 (mean) AUT: 753 (mean) |
IN: 30 (median) IM: 45 (median) AUT: 7.50 (median) |
SBP increase (mean mmHg): IN: 23.6 IM: 11.9 AUT: 18.2 HR (mean beats/min): IN: 17.3 IM: 9.71 AUT: 12.3 |
| Casale et al. [42] | Phase 1 crossover study | 45 allergic rhinitis patients | IN (2 mg) vs. IM (self-administered 0.3 mg) | IN: 421 IM: 322 |
IN: 30 IM: 45 |
SBP increase (mean mmHg): IN, 20 mmHg; IM, 13 mmHg |
| Oppenheimer et al. [43] | Mixed-model analysis study | 21 adults with URTI or in normal conditions | IN (2 mg) | URTI: 490 Normal conditions: 570 |
10–15 min for early absorption | No significant differences between subjects with URTI or in normal conditions |
| Greenhawt M. et al. [44] | Pooled four crossover study | Adults | IN, opposite vs. same nostrils (13.2 mg) IM (0.3 mg) |
IN, same nostril: 332 IN, opposite nostril: 262.8 IM: 285.7 |
IN, same nostril: 20.1 IN, opposite nostril: 25.1 IM: 20 |
HR (mean beats/min): IN, same nostril: 8.8 IN, opposite nostril: 6.5 IM: 5.9 |
| Fleischer et al. [56▪▪] | Phase 1, single-dose studies | Children 4–18 years | IN, 1 mg (15–30 kg of weight) IN, 2 mg (>30 kg of weight) |
IN, 1 mg: 651 IN, 2 mg: 690 |
IN, 1 mg: 20 IN, 2 mg: 29.5 |
SBP increase (mean mmHg): IN, 1 mg: 13.4 IN, 2 mg: 12.2 HR (mean beats/min): IN, 1 mg: 18.5 IN, 2 mg: 16.9 |
AUT, autoinjectors; SBP, systolic blood pressure; Cmax, maximum blood concentration; HR, hearth rate; IM, intramuscular; IN, intranasal; PD, pharmacodynamic; Tmax, time to reach the maximum blood concentration; URTI, upper respiratory tract infection.