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ISTA Pharmaceuticals Reports Positive Preliminary Results from its Phase 1/2 Clinical Study of Bepotastine Besilate Nasal Spray for the Treatment of Symptoms Associated with Seasonal Allergic Rhinitis
Date:10/6/2010

nasal symptoms, with the most rapid improvement seen for drug-related reductions in sneezing and nasal itching.

The PK information collected in the study supported the principle that the systemic bioavailability of bepotastine from the nasal sprays approximated dose proportionality. With regards to safety, the total number of adverse events was similar in all treatment groups, with the most common adverse events reported being bitter taste, headache, nasal pain and discomfort, and nosebleed. These adverse events were generally mild. Additionally, no serious adverse events were observed during the Phase 1/2 study.  

About Allergic Rhinitis

According to the American Academy of Allergy Asthma & Immunology (AAAAI), approximately 60 million Americans are affected by allergic rhinitis, an inflammation of the nasal passages caused by exposure to certain allergens, such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Allergic rhinitis is characterized by a number of symptoms, including sneezing, nasal congestion, nasal itching and runny nose.  The eyes, ears, sinuses, and throat also can be affected. Current treatments for allergic rhinitis include antihistamines, mast cell stabilizers, anti-inflammatories, and steroids.  Based on data from IMS Health in the U.S., approximately 43.3 million prescriptions were filled for nasal allergy treatments in 2009, resulting in sales of approximately $2.2 billion.

About bepotastine besilate

Bepotastine besilate is a non-sedating, highly selective antagonist of the histamine H1 receptor.  It has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues.  The compound's primary mechanisms of action are believed to make it an effective treatment for nasal symptoms associated with allergic rhinitis.

Bepotastine besilate has been approved in Japan for systemic use in the
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SOURCE ISTA Pharmaceuticals, Inc.
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