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Efficacy

24-hour relief‡ for SAR and PAR nasal symptoms

Efficacy SAR

In a placebo-controlled clinical trial

OMNARIS significantly reduced Total
Nasal Symptom Score for a FULL
24 HOURS‡ all season long16,20

Ciclesonide 200 mcg vs placebo: -1.87 vs 1.03 (P<0.001)

Study design: A 4-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, clinical trial of SAR patients 12 years of age and older (n=327). The primary endpoint of the study was the least square (LS) mean change from baseline in average of AM and PM reflective TNSS (rTNSS) over days 1-14; these results were statistically significant.20 Data shown are for the secondary endpoint, change from baseline in average AM iTNSS.16

Efficacy PAR

In a placebo-controlled clinical trial

OMNARIS significantly reduced Total
Nasal Symptom Score for a FULL
24 HOURS‡ in PAR patients18,19

Ciclesonide 200 mcg vs placebo: -1.99 vs 1.46 (P=0.004)

Study design: A 6-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, clinical trial of PAR patients 12 years of age and older (n=461). The primary endpoint of the study was patient-evaluated change from baseline in average of AM and PM rTNSS over days 1-42; these results were statistically significant.18 Data shown are for the secondary endpoint, change from baseline in average AM iTNSS.19

OMNARIS significantly reduced the Reflective Nasal Symptom Score in all 4 nasal symptoms16 Congestion Nasal Itching Sneezing Runny Nose

Ciclesonide 200 mcg vs placebo: -2.40 vs 1.5 (P<0.001)

Study design: A 4-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, clinical trial of SAR patients 12 years of age and older (n=327). Data shown are for the secondary endpoint, reductions in the individual symptoms as measured by average of AM and PM rTNSS (LS mean change from baseline over days 1-14).16,20

‡ Symptom relief begins within 24-48 hours after the first dose.

OMNARIS offers efficacy that lasts over time

In a 52-week,
long-term safety trial,
the efficacy demonstrated
with OMNARIS was similar to trials of a shorter duration.15

‡ Symptom relief begins within 24-48 hours after the first dose.

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OMNARIS (ciclesonide) Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and with perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Important Safety Information

Patients using drugs that suppress the immune system are more susceptible to infections. Chickenpox and measles, for example, can have a more serious or even fatal course in children or adults taking corticosteroids. In clinical studies with OMNARIS Nasal Spray, the development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. Intranasal corticosteroids should be used with caution, if at all, in patients with tuberculosis, untreated fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex.

Patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Rare instances of nasal septum perforation, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal application of corticosteroids. Close follow-up is warranted in patients with a change in vision and with a history of glaucoma and/or cataracts.

If recommended doses of intranasal corticosteroids are exceeded, or in susceptible individuals used at recommended dosages, symptoms of hypercorticism may occur. If such changes occur, topical corticosteroids should be discontinued slowly.

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including OMNARIS Nasal Spray, should be monitored routinely.

The most common side effects that may occur with OMNARIS are headache, epistaxis, nasopharyngitis and ear pain.

References

  • 1. OMNARIS [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc; May 2010.
  • 2. Meltzer EO. Formulation considerations of intranasal corticosteroids for the treatment of allergic rhinitis. Ann Allergy Asthma Immunol. 2007;98(1):12-21.
  • 15. Chervinsky P, Kunjibettu S, Miller DL, et al. Long-term safety and efficacy of intranasal ciclesonide in adult and adolescent patients with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2007;99(1):69-76.
  • 16. Data on file, CSR 401. Florham Park, NJ: Altana Pharma US, Inc; December 21, 2004.
  • 18. Meltzer EO, Kunjibettu S, Hall N, et al. Efficacy and safety of ciclesonide, 200 μg once daily, for the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2007;98(2):175-181.
  • 19. Data on file, CSR 402. Florham Park, NJ: Altana Pharma US, Inc; April 5, 2005.
  • 20. Ratner PH, Wingertzahn MA, van Bavel JH, Hampel F, Darken PF, Shah T. Efficacy and safety of ciclesonide nasal spray for the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol. 2006;118(5):1142-1148.

© 2011 Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd., and is a registered trademark of Dainippon Sumitomo Pharma Co. Ltd.
OMNARIS is a registered trademark of Nycomed GmbH, used with permission.