ISTA Pharmaceuticals (NASDAQ:ISTA) announced Wednesday its positive preliminary results from a Canadian phase 1/2 clinical study of bepotastine besilate nasal spray, a treatment for symptoms associated with seasonal allergies.
The findings, based on a placebo-controlled study of 82 patients, demonstrated two of the three bepotastine besilate concentrations tested were effective in relieving patients' nasal symptoms after exposure to seasonal allergens, the company said. The most rapid improvement was seen in sneezing and nasal itching, according to ISTA.
The data also showed the drug to be well-tolerated, with mild adverse events consistent with those observed in other antihistamine nasal sprays.
Based on the positive results, ISTA plans to submit an Investigational New Drug (NYSE:IND) Application to the U.S. FDA and to initiate phase 2 clinical studies of the nasal spray before the end of the year, using one of the most potent allergens, Mountain Cedar pollen.
The company expects to report preliminary phase 2 data during the first half of 2011.
According to the American Academy of Allergy Asthma & Immunology, 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.
It is characterized by a number of symptoms, including sneezing, nasal congestion, nasal itching and runny nose. 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.
Bepotastine besilate has been approved in Japan for systemic use in the treatment of allergic rhinitis since 2000 under the brand name TALION. In 2006, ISTA licensed the exclusive North American ophthalmic rights to bepotastine besilate and in 2007, ISTA licensed exclusive North American rights to nasal dosage forms.
ISTA's eye drop formulation of bepotastine besilate, BEPREVE 1.5%, was approved by the U.S. FDA in September 2009 for the treatment of ocular itching associated with allergies.
Based in Irvine, California, ISTA is the fourth largest branded prescription eye care business in the United States, with an expanding focus on allergy therapeutics. The company currently markets four products, including treatments for ocular inflammation and pain post-cataract surgery, glaucoma and ocular itching associated with allergic conjunctivitis.
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