Teva Pharmaceutical Industries Ltd. announced results from a phase III study of Qnaze (beclomethasone dipropionate [BDP]) HFA, its nasal aerosol corticosteroid in development for the treatment of perennial allergic rhinitis (PAR) and seasonal allergic rhinitis (SAR). Results of the study evaluating patients with PAR showed the once-daily, non-aqueous formulation achieved all primary and secondary efficacy endpoints, demonstrating significantly greater relief of nasal symptoms, including runny nose, nasal congestion, nasal itching and sneezing, compared with placebo. Consistent with previous studies, the product demonstrated safety similar to placebo.

Teva recently reported successful results from a phase III SAR study of its intranasal corticosteroid (INS), Qnaze (320 mcg/day), at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting in 2010. In this study, Teva's INS demonstrated significant improvements in nasal symptoms compared with placebo. Additionally, Teva is evaluating the long-term safety and effect of its INS on the hypothalamic pituitary-adrenal (HPA) axis in studies that are currently underway. The successful study results serve to further support the long-term respiratory strategy that Teva unveiled in a November 2010 analyst review, by including entry into the allergic rhinitis space.

This phase III, randomized, double-blind, placebo-controlled, parallel-group clinical study assessed the efficacy and safety of Teva's INS in the treatment of PAR in subjects 12 years of age and older. At 35 US investigational sites, 470 PAR patients were randomized to receive Qnaze (320 mcg, once-daily) or placebo as a nasal aerosol over a six-week period.

For the primary endpoint, the results showed a significant (p<0.001) change from baseline in the average morning and evening subject-reported reflective Total Nasal Symptom Score (rTNSS), a standard instrument for measuring nasal allergy symptoms. Similarly, the change in instantaneous TNSS (iTNSS), a secondary endpoint, was significantly greater versus placebo. Additionally, for both of these measures, all four individual nasal symptom scores of runny nose, nasal congestion, nasal itching and sneezing demonstrated significant improvement versus placebo.

Teva's INS was also well tolerated and the safety profile was similar to that of placebo. The most common treatment-emergent adverse events were nasal discomfort and nosebleed that were similar with both treatments.

"We are excited by the promising results we've seen to date for Qnaze in the treatment of both seasonal and perennial allergic rhinitis," said Prof. Yitzhak Peterburg, Teva's group vice president, global branded products. "As Teva continues to expand its presence in the respiratory category, we remain committed to addressing the unmet needs among the 60 million patients in the US who suffer with allergic rhinitis."

Currently, the only intranasal corticosteroids available for the treatment of PAR and SAR are products with an aqueous or "wet" spray. Aerosol spray formulations became unavailable in the U.S. following the US Food and Drug Administration's (FDA) decision to phase out all metered dose inhalers (MDIs) that used ozone-depleting chlorofluorocarbon (CFC) propellants. Teva's INS is delivered as a non-aqueous aerosol formulation propelled by hydrofluoroalkane (HFA), which is environmentally friendly.

"We are encouraged by the positive efficacy and safety results from the phase III perennial allergic rhinitis trial," said Tushar Shah, MD, senior vice president, Teva Global Respiratory Research and Development. "The aerosol delivery system offered by Qnaze may meet the needs of physicians and patients who are looking for an alternative treatment to currently available wet sprays."

Allergic rhinitis (AR) is a chronic inflammatory disease characterized by symptoms such as sneezing, nasal itch, rhinorrhea, and nasal congestion. For many AR patients, nasal congestion or a stuffy nose may be the most frequent and bothersome symptom. According to a recent survey, patients suffer considerable discomfort during allergy attacks, such that nearly two out of five (38%) said their discomfort was not tolerable without relief. Based on the available evidence, intranasal corticosteroids are the most effective treatment options for patients with AR. Morbidity associated with AR can be significant. Effective treatment of AR may improve asthma control when both diseases coexist.

In the US, 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 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 $11.2 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.

Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,250 molecules and a direct presence in over 60 countries.