Well-characterized safety profile

AEs Occurring in ≥ 3% of Patients and More Common Than Placebo1*

Adverse Event (AE) Placebo EDS
(N=161)
n (%)
XHANCE
186 mcg BID
(N=160)
n (%)
XHANCE
372 mcg BID
(N=161)
n (%)
Epistaxis 4 (2.5) 19 (11.9) 16 (9.9)
Nasopharyngitis 8 (5.0) 3 (1.9) 12 (7.5)
Nasal septal ulceration 3 (1.9) 11 (6.9) 12 (7.5)
Nasal congestion 6 (3.7) 7 (4.4) 9 (5.6)
Acute sinusitis 6 (3.7) 7 (4.4) 8 (5.0)
Headache 5 (3.1) 8 (5.0) 6 (3.7)
Pharyngitis 2 (1.2) 2 (1.3) 5 (3.1)
Nasal mucosal ulceration 2 (1.3) 6 (3.8) 4 (2.5)
Nasal mucosal erythema 6 (3.7) 9 (5.6) 8 (5.0)
Nasal septal erythema 3 (1.9) 6 (3.8) 7 (4.3)

*AEs reported in patients with nasal polyps in placebo-controlled studies.

The AEs observed during open-label trials in subjects with chronic sinusitis with and without nasal polyps were similar to the AEs reported in placebo-controlled clinical trials in patients with nasal polyps.1
Review information on dosing and administration of XHANCE.
Reference:
  1. Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.