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| |  Astelin (Azelastine Hydrochloride) Nasal Spray Effective When Allergy Symptoms Respond Inadequately To Treatment With Claritin (Loratadine) SOMERSET, NJ -- August 18, 2003 -- Astelin® Nasal Spray (azelastine hydrochloride) provides effective symptomatic relief in patients with moderate to severe allergic rhinitis who have had an unsatisfactory response to treatment with Claritin® (loratadine), according to data published in the August 2003 issue of Annals of Allergy, Asthma and Immunology. "Our study shows that for those patients who experience limited symptom relief with the oral antihistamine Claritin, Astelin Nasal Spray should be considered an effective alternative to switching to another oral antihistamine or to using multiple antihistamines," according to William Berger, MD, MBA, study author and clinical professor, College of Medicine, Department of Pediatrics, Division of Allergy and Immunology, University of California, Irvine. Allergic rhinitis is the fifth most prevalent chronic disease in the United States, affecting up to 40 million men and women. Symptoms commonly associated with allergic rhinitis are runny nose, sneezing, nasal congestion, and itchy eyes. Allergic rhinitis costs the nation approximately $5.3 billion in direct and indirect costs, including time lost from work and school. It also can lead to a number of complications, including sinusitis, eustachian-tube dysfunction, sleep disturbances, asthma, and ear infections. "As this week marks the beginning of the fall allergy season, sufferers will soon find themselves seeking relief from the often debilitating symptoms of seasonal allergic rhinitis," said Anthony H. Wild, PhD, Chairman and Chief Executive Officer of MedPointe Pharmaceuticals. "The availability of Claritin over-the-counter has changed the landscape for allergy patients, especially those enrolled in a prescription coverage plan. We are pleased to provide Astelin Nasal Spray, which this encouraging new study shows is an effective treatment option with multiple benefits for those nasal allergy sufferers whose symptoms are not improved by Claritin." About The Study The multicenter, placebo-controlled, randomized, double-blind trial was conducted at 21 sites during the 2002 fall allergy season. The study enrolled 440 male and female patients, 12 years of age and older, all of whom had experienced unsatisfactory results on Claritin monotherapy for a seven-day period prior to the start of the trial. Study subjects were divided into four groups for a two-week period, using either Astelin Nasal Spray and oral placebo, Astelin Nasal Spray and Claritin (10 mg), Clarinex(R) (desloratadine) (5 mg) and placebo nasal spray, or placebo nasal spray and oral placebo. Study results showed that patients treated with Astelin Nasal Spray showed an improvement in their overall Total Nasal Symptom Score (TNSS), experiencing statistically significant symptom relief compared to placebo. A total of 428 of the 440 randomized patients completed the two-week, double-blind treatment period. Of the 12 patients who did not complete the study, four discontinued due to an adverse event, and eight discontinued for administrative or other reasons. Drug efficacy was based on the TNSS measurement tool, defined as the sum of individual symptom severity scores for runny nose, sneezing, itchy nose, and nasal congestion. After two weeks of treatment, the mean percentage change in the overall TNSS from baseline with Astelin Nasal Spray was significantly greater than that of placebo. The study also found the combination of Astelin Nasal Spray and Claritin showed no additional clinical benefit compared to Astelin monotherapy. About Astelin Astelin Nasal Spray is the only US Food and Drug Administration (FDA)- approved prescription second-generation antihistamine formulated for intranasal administration and indicated to treat the symptoms of both seasonal allergic rhinitis in adults and children five years and older and nonallergic vasomotor rhinitis in adults and children 12 years of age and older. Astelin Nasal Spray may cause side effects in some patients. The most commonly reported adverse events in seasonal allergic rhinitis and nonallergic vasomotor rhinitis patients 12 years of age and older were bitter taste, headache, somnolence, and nasal burning. The adverse event profile in seasonal allergic rhinitis patients five to 11 years of age was similar to that in the adult population. Discontinuation rates due to adverse events in patients taking Astelin Nasal Spray in the seasonal allergic rhinitis and nonallergic vasomotor rhinitis clinical trials were no different than those for placebo. About Fall Allergies As the fall allergy season begins this week in the Southeastern United States, nasal allergy sufferers will face the annual onslaught of fall allergens, such as ragweed, a common plant most often responsible for fall allergy symptoms. Ragweed is found along roadsides, in vacant lots and fields, and in almost any other sunny spot. It is most prevalent throughout the Northeast, South, and Midwest. Other common fall allergens include outdoor molds found in soil, vegetation, and rotting wood. These allergens are most prevalent in the North during the fall and in the South and on the West Coast year-round. Additionally, trees, flowers, and weeds that pollinate in the fall -- including sagebrush, pigweed, tumbleweed, and Russian thistles -- are troublesome in the Southern United States.
SOURCE: MedPointe Pharmaceuticals
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