Sepracor announces preliminary results from OMNARIS HFA Phase III study for seasonal allergic rhinitis

Sepracor Inc. announced today the preliminary results of a large-scale, 671-patient Phase III study of OMNARIS^® (ciclesonide) HFA, an aerosol nasal formulation of ciclesonide, for the treatment of seasonal allergic rhinitis (SAR) in adult and adolescent patients. In this study, OMNARIS HFA met its primary efficacy endpoint by demonstrating a statistically significant reduction versus placebo in the reflective total nasal symptom score averaged over a two-week treatment period. The total nasal symptom score, commonly referred to as TNSS, assesses the common allergy symptoms of nasal congestion, itching, sneezing, and runny nose and was recorded twice daily, once in the morning and once in the evening. In a previous Phase III SAR study of OMNARIS HFA, both ciclesonide doses (80 μg and 160 μg once daily) demonstrated clinically meaningful and statistically significant improvements in nasal symptoms compared with placebo.

“OMNARIS in an HFA formulation has meaningful potential to provide physicians with a new method to treat patients suffering from nasal allergies. In addition to its efficacy, OMNARIS HFA offers the benefits of a unique delivery system that may help physicians improve patient comfort and compliance.”

"With the positive preliminary results obtained in this second Phase III clinical study, we continue to be encouraged by the potential benefits OMNARIS HFA offers those patients suffering from the effects of allergic rhinitis," said Saburo Hamanaka, Chairman and Chief Executive Officer of Sepracor. "We also believe the novel metered-dose device that we are developing to deliver this important treatment therapy is a truly differentiated, first-in-class delivery system that offers Sepracor an exciting opportunity to expand our leadership position within the respiratory marketplace."

One potential benefit of OMNARIS HFA and its differentiated delivery system is that the product may be able to reduce post-nasal drip and back-of-the-throat run-off that is commonly associated with currently available intranasal aqueous-based corticosteroids for the treatment of allergic rhinitis. The Allergies in America Survey, published in 2006, reports that approximately 33% of survey participants find "dripping down the throat" to be a moderately or extremely bothersome aspect of intranasal steroid products, and approximately 25% of survey participants have discontinued use of a nasal allergy prescription due to bothersome side effects. In contrast, the innovative nasal HFA device is designed to deliver a fine, dry mist of OMNARIS HFA medication to a patient's nose.

Ciclesonide is the active ingredient in OMNARIS HFA. Intranasal corticosteroids are well accepted as first-line therapy for the treatment of allergic rhinitis. OMNARIS HFA is being developed by Sepracor for commercialization in the U.S. under an exclusive distribution agreement with Nycomed.

"This is the second large-scale Phase III study Sepracor has completed and we are, once again, encouraged by the preliminary positive results we have received," said Antony Loebel, M.D., Executive Vice President, Clinical Research and Medical Affairs at Sepracor. "OMNARIS in an HFA formulation has meaningful potential to provide physicians with a new method to treat patients suffering from nasal allergies. In addition to its efficacy, OMNARIS HFA offers the benefits of a unique delivery system that may help physicians improve patient comfort and compliance."