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TEVA: QNASLTM Phase III Data Indicate Investigational Therapy with New Mode of Delivery has Positive Safety and Effective Profile

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced positive findings from four Phase III clinical studies that examined the efficacy and safety profile as well as impact on quality of life of QNASLTM (beclomethasone dipropionate Nasal Aerosol. QNASLTM is a non-aqueous, “dry” nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis. The data were presented today at the 2012 American Academy of Allergy, Asthma and Immunology (AAAAI) Meeting in Orlando, Florida.

In a long-term (52-week), double-blind, placebo-controlled, parallel-group study, 529 patients with PAR, aged 12 years and older, were randomized to receive once-daily treatment with QNASLTM 320 mcg or placebo. The primary endpoint, the results for which were previously released1, showed a significant (p<0.001) change from baseline weekly averages of the subject reported 24-hour reflective nasal symptom scores (rTNSS) over the first 30 weeks of the treatment period. Additional 52 weeks of treatment data reported today further demonstrated the safety and efficacy profile of QNASLTM treatment by showing significantly greater improvements from baseline over a 24-hour period in both rTNSS (-1.09 [95% CI: -1.6, -0.6], p<0.001) and instantaneous nasal symptom scores (iTNSS) (-1.10 [95% CI: -1.6, -0.6]; p<0.001) compared with placebo. Furthermore, greater improvements in individual nasal symptoms (nasal congestion, nasal itching, rhinorrhea and sneezing) were also demonstrated in the QNASLTM group compared to placebo. QNASLTM was generally well tolerated with a safety profile similar to placebo with the exception of epistaxis, which occurred more frequently with the active treatment. The most commonly reported adverse events (5% or more subjects) were nasopharyngitis, epistaxis, upper respiratory tract infection, sinusitis and headache. Treatment difference in the average AM and PM subject-reported rTNSS over the first 6-week treatment period from the same study were also reported. The LS mean treatment difference between QNASLTM 320 mcg/day and placebo was –0.78 (95% CI: -1.2, -0.5) (p<0.001).

Posted-In: News FDA

 

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