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Astelin, First Prescription Antihistamine Spray For Seasonal Allergic Rhinitis SAN FRANCISCO, Feb. 24, 1997 -- Astelin(TM) (azelastine HCI) Nasal Spray, 137 mcg, will be commercially available in the U.S. in March 1997. Wallace Laboratories made the announcement today at the annual meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI). Astelin Nasal Spray is indicated for the treatment of symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 12 years and older. The recommended dose is two sprays per nostril twice daily. On days when symptoms are present, Astelin Nasal Spray offers first-dose response, with long-lasting, 12-hour. It may be used for episodes or all season long. Eli Meltzer, MD, a physician with the Allergy and Asthma Medical Group and Research Center in San Diego and an Astelin Nasal Spray clinical investigator said, "With Astelin Nasal Spray, presymptom, prophylactic dosing is not required, providing an option for allergy sufferers to comply with a treatment regimen." Seasonal allergic rhinitis, or hay fever, is one of the most common conditions in the U.S. affecting approximately 10% to 30% of Americans. "The fourth most frequent diagnosis among patients 15 to 44, allergic rhinitis accounts for many return visits to physicians. When you consider that 20 to 40 million Americans suffer from allergic rhinitis and spend some $1.5 billion annually on prescriptions, it is obvious there is a financial strain on the healthcare system," said Dr. Meltzer. "Co-morbid (related) diseases, including asthma, sinusitis and otitis media, raise the total national cost of allergic rhinitis to $10 billion." Efficacy Profile -- U.S. Placebo-Control Clinical Trials in patients with seasonal allergic rhinitis, Astelin Nasal Spray significantly improved a complex of symptoms which included rhinorrhea, sneezing, and nasal pruritus. Side Effects In clinical trials, the side effect profile was generally mild or moderate. The most commonly occurring adverse events recorded in Astelin Nasal Spray clinical trials were bitter taste, headache, somnolence, and nasal burning. The incidence of discontinuation due to adverse events in patients receiving Astelin Nasal Spray in placebo-controlled efficacy trials was not significantly different than vehicle placebo (2.2% vs 2.8%, respectively). Special Prescribing Considerations -- There is no effect on the QTc interval. Astelin(TM) (azelastine HCI) Nasal Spray, 137 mcg, may be used with ketoconazole and erythromycin. -- Importantly, Astelin Nasal Spray can be administered to seasonal allergic rhinitis patients with concomitant asthma, conditions that affect over 40 million people in the United States. -- Astelin Nasal Spray has no coprescribing restrictions with medications such as antihistamines, nasal steroids, decongestants, or theophylline. Patients should be advised that concurrent use with alcohol or other CNS depressants should be avoided as additional reductions in alertness and additional impairment of CNS performance may occur. Astelin Nasal Spray avoids problems common with some other allergy therapies; it does not irritate the nasal passages, there is no limitation on duration of use, and patients do not experience rebound effects. E-mail this page to a friend or colleague! To print, use this version