The pivotal trial primary and secondary end points both met statistical significance with Teva's HFA Nasal Aerosol, which demonstrated clinical efficacy in patients with SAR versus placebo. The product was also generally well tolerated and comparable to placebo. The most common adverse events reported were nasal discomfort, headache, epistaxis (nosebleed), nausea and urticaria (hives).
About Allergic Rhinitis
Allergic rhinitis (AR) is a chronic inflammatory disease characterized by sneezing, nasal itch, rhinorrhea, and nasal congestion as symptoms, in addition to allergic conjunctivitis in many subjects. For many AR patients, a stuffy nose may be the most irritating symptom; however, a recent survey reported almost half (46%) of parents of children with allergic rhinitis reported severe symptoms such as headache and ear and facial pain. Based on the available evidence, intranasal corticosteroids are the most effective treatment options for patients with AR. While AR itself is not life-threatening (unless accompanied by severe asthma or anaphylaxis), morbidity associated with the condition can be significant. The presence of AR commonly exacerbates asthma, and may increase the risk of asthma attacks, emergency visits and hospitalizations.
In the U.S., the prevalence of AR has increased during the past three decades; it is recently estimated at 20% in the general adult population and closer to 40% in children. Of the estimated 60 million Americans affected with AR, approximately 20% have SAR, 40% have perennial allergic rhinitis (PAR), and 40% have a combination of the two (i.e., PAR with seasonal exacerbation) depending on the allergen sensitivity. Because of its prevalence and health effect, AR is associated with considerable direct and indirect costs. An estimate of $2.7 billion in healthcare costs, 12 million physician office visits, 2 million days of school absences and 3.5 million lost work days per year are attributed to AR. In addition, the presence of co-morbidities, such as asthma and sinusitis, further increase AR - related treatment costs.
Sunday, August 22, 2010
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