OMNARIS ™ offers patients powerful, full 24-hour relief from seasonal and perennial allergic rhinitis symptoms ~
Oakville, ON – April 24, 2008 –
Canadian allergic rhinitis (AR) sufferers now have a new treatment option to help provide relief of common symptoms – nasal discharge, congestion, itchy nose and itchy/watery eyes.1 Health Canada has approved OMNARIS™ (ciclesonide nasal spray), a uniquely formulated intranasal corticosteroid (INCS) for the treatment of seasonal allergic rhinitis (SAR), including hayfever, and perennial allergic rhinitis (PAR) in adults and adolescents 12 years of age and older.1 OMNARIS™ is marketed in Canada by Nycomed Canada Inc. (previously ALTANA Pharma Inc.).
The approval of OMNARIS™ was based on results from double-blind, randomized, placebo-controlled studies, which demonstrated that patients treated with OMNARIS™ 200 mcg once-daily had a significant decrease in total nasal symptom scores (TNSS) compared to placebo.1 The improvements in TNSS were maintained over the full 24-hour dosing interval, with a fast onset of symptom relief.1 In addition, OMNARIS™ exhibited a low incidence of nasal dryness (0.04 per cent), throat irritation (0.2 percent) and epistaxis (2.7 percent after 2-6 weeks in SAR; 8.4 per cent after 52 weeks in PAR).1
“Many of my patients want fast-acting, long-lasting symptom relief, but complain about nasty side effects such as nose bleeds or nasal dryness that they’ve experienced while taking other INCS treatments. Sometimes these side effects can be as frustrating and inconvenient for patients as the AR symptoms themselves,” said Dr. Harold Kim, an allergist and president of the Canadian Network of Asthma Care.
“OMNARIS™ is a welcome new treatment option for Canadians living with AR as it provides very effective, full 24 -hour symptom relief, with an excellent safety and tolerability profile."
Quality Of Life
Canada has one of the highest incidences of allergic rhinitis in the world.2 Seasonal Allergic Rhinitis (SAR) is triggered by pollen from trees, grass and weeds, and as a result, sufferers experience sneezing, nasal congestion, nasal itching, rhinorrhea (runny nose), itchy, watery and red eyes. Perennial Allergic Rhinitis (PAR) on the other hand, is triggered by allergens, such as dust mites or cat allergens, which are commonly found indoors at any time of year. These symptoms can be bothersome for AR sufferers, and if left untreated, can have a negative impact on their sleep quality, job performance and overall quality of life, resulting in decreased productivity and increased medical and work/school related cost. 3
“OMNARIS™ is a safe and effective INCS that has been proven to maintain its effectiveness over a full 12 months.1 This allows people living with AR to have the freedom to enjoy the activities that they love all year round without having to deal with the inconvenience of allergy symptoms, or worry about side effects.”, said Dr. Kim.
Powerful yet gentle relief
OMNARIS™ is uniquely formulated and is delivered in a hypotonic suspension. OMNARIS™ does not contain benzalkonium chloride (BKC) or phenylethyl alcohol, and its low spray volume (70 mcl per actuation) may help to reduce the incidence of side effects related to the nose and throat. 1 In addition, OMNARIS™ has an excellent safety profile compared to placebo, with no intraocular pressure changes or HPA-axis suppression. 1
In addition to Canada, OMNARIS™ is currently approved in the United States.
About OMNARIS™
OMNARIS™ (ciclesonide nasal spray) is an unscented, metered-dose, manual spray formulation. The recommended dose of OMNARIS™ is 200 mcg per day administered as two sprays (50 mcg/spray) in each nostril once daily. The maximum total daily dosage should not exceed two sprays in each nostril (200 mcg/day).1
About Nycomed Canada Inc.
Nycomed Canada Inc. is the Canadian subsidiary of Nycomed GmbH; a European based, privately owned research-based company. Through its innovative products and dedicated people, Nycomed is committed to improving the health of Canadians. In Canada, Nycomed is active in the therapeutic areas of gastroenterology, respirology and dermatology. Headquartered in Oakville, Ontario, the company employs more than 265 people across the country. Employees take pride in the corporate culture, and research and development is vital to the business. For more information, please visit http://edit.nycomed.ca.nycomed.local/NR/exeres/50E7EA77-54AB-4D3D-97EA-1DA2A5886EC5.htm?NRMODE=Unpublished&wbc_purpose=Basic&WBCMODE=PresentationUnpublished. OMNARIS™ is a registered trademark of Nycomed GmbH and is used under license.
References
1 OMNARIS™ Product Monograph, December 10, 2007
2 Allergic Living Magazine . The Hayfever Handbook Accessed on April 3, 2008 http://www.allergicliving.com/features.asp?copy_id=55
3 Nathan, Robert A. The Burden of Allergic Rhinitis. Allergy and Asthma Proceedings. January-February 2007, Vol. 28, No 1, p. 3