-
In a large-scale Phase III study, OMNARIS delivered in an aerosol
nasal formulation propelled by HFA (hydrofluoroalkane) met both its
primary and key secondary endpoints
-
If developed successfully and FDA approved, OMNARIS HFA could be
the first nasal HFA formulation to be available for patients in the
U.S. for the treatment of allergic rhinitis
-
The U.S. market for nasal corticosteroids is estimated at
approximately $2 billion1
Sepracor Inc. (Nasdaq: SEPR) announced today the results of a
large-scale, 707-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 in the 24-hour
reflective total nasal symptom score (TNSS), which assesses the common
allergy symptoms of nasal congestion, itching, sneezing and runny nose,
versus placebo. In addition, OMNARIS HFA statistically significantly met
its key secondary endpoints of improvement in the 24-hour instantaneous
TNSS and the 24-hour reflective total ocular symptom score (TOSS) versus
placebo. Ocular symptoms, which can include itching, tearing and redness
of the eyes, can be particularly troublesome and are present in a large
number of patients with SAR.
“We are very excited about these preliminary Phase III results since
OMNARIS HFA is a differentiated asset with the potential to become a
significant growth product for Sepracor. We are developing OMNARIS in a
novel, HFA metered-dose device that we believe is a first-in-class
delivery system for the treatment of allergic rhinitis,” said Adrian
Adams, President and Chief Executive Officer of Sepracor. “This
late-stage clinical candidate represents another planned step forward in
our near- and mid-term corporate objectives of expanding and advancing
our pharmaceutical product pipeline towards creating shareholder value
over time.”
OMNARIS HFA and OMNARIS Nasal Spray both represent a potential
improvement in delivery systems that may be able to reduce post-nasal
drip and back-of-the-throat run-off associated with some intranasal
aqueous-based corticosteroids for the treatment of allergic rhinitis.
The HFA device is designed to deliver a fine, dry mist of medication,
administered by a metered-dose device, to a patient’s nose. The
Allergies in America Survey, published in 2006, reports that
approximately 33% of respondents find "dripping down the throat" to be
moderately or extremely bothersome, and approximately 25% of respondents
have discontinued use of a nasal allergy prescription due to bothersome
side effects.
Ciclesonide is the active ingredient in OMNARIS HFA as well as OMNARIS
Nasal Spray, which is a product approved by the U.S. Food and Drug
Administration (FDA) that is indicated for the treatment of nasal
symptoms associated with seasonal and perennial allergic rhinitis.
Sepracor launched OMNARIS Nasal Spray in April 2008. Intranasal
corticosteroids, such as OMNARIS Nasal Spray, are well accepted as
first-line therapy for the treatment of allergic rhinitis. Ciclesonide
is developed, marketed and commercialized by Sepracor in the U.S. under
an exclusive distribution agreement with Nycomed GmbH (Nycomed).
“We are encouraged by these study results and plan to initiate a Phase
III perennial allergic rhinitis study this year,” said Mark H.N.
Corrigan, M.D., Executive Vice President, Research and Development at
Sepracor. “HFA formulations that deliver medication for the treatment of
nasal allergies are currently not available. We are excited about the
potential for OMNARIS HFA and believe that patients may benefit from
this new delivery system.
