Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) today reported positive findings from four Phase III clinical studies for its QNASL nasal spray. The trials examined the efficacy and safety profile as well as impact on quality of life of the treatment for seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). Teva presented the data today at the 2012 American Academy of Allergy, Asthma and Immunology (AAAAI) meeting in Orlando, Florida.
Teva said that in a 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 QNASL 320 mcg or placebo. The primary endpoint, the results for which have been previously released, showed a significant change from baseline weekly averages of the subject reported 24-hour reflective nasal symptom scores over the first 30 weeks of the treatment period.
Further 52-week treatment data reported today demonstrated the safety and efficacy profile of QNASL treatment by showing significantly greater improvements from baseline over a 24-hour period in both rhinitis symptoms and instantaneous nasal symptom scores compared with placebo.
The trial also showed greater improvements in individual nasal symptoms (nasal congestion, nasal itching, rhinorrhea and sneezing) in the QNASL group compared with the placebo group. Teva reported that QNASL 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.
Practicing allergist and co-founder of the Dallas Asthma and Allergy Center Dr. Gary N. Gross said, “The long term data validated the efficacy and safety profile of QNASL and demonstrated positive results experienced by patients using the new ‘dry’ aerosol delivery. Since allergic rhinitis is one of the most common allergic diseases in the US, affecting more than one in five people, it’s important for there to be a variety of treatment options available to patients experiencing ongoing challenges with the condition.”
To evaluate the safety of QNASL, a double-blind placebo and active controlled parallel-group study was conducted to determine the effect of six weeks of therapy with QNASL on hypothalamic-pituitary adrenal axis function (HPA-axis) in adult and adolescent patients. As previously reported by Teva, treatment with QNASL at a dose of 320 mcg/day was not associated with HPA-axis suppression in adult and adolescent subjects with PAR, as demonstrated by the geometric mean ratio for QNASL. However, HPA-axis function suppression is known to have an impact on growth in adolescent subjects. Therefore, a subgroup analysis of 25 adolescents from the same study, randomized to treatment with QNASL 320 mcg/day, placebo or an active control of prednisone 10 mg/day showed that, after 6 weeks, the geometric mean serum cortisol weighted value in patients treated with QNASL was similar to those treated with placebo but treatment with active control oral prednisone resulted in significant suppression of serum cortisol levels. These results, Teva said, further support the lack of HPA-axis suppression with QNASL treatment reported previously.
Finally, Teva reported new results from a two-week, randomized, double-blind, placebo-controlled study in 715 children (6-11 years of age) with SAR. The study sought to measure the average morning and evening rTNSS with once-daily treatment with QNASL at dosages of 80 mcg or 160 mcg, as well as the safety profile compared to placebo. Improvements in both AM and PM rTNSS were significantly greater for those treated with QNASL 80 mcg and 160 mcg compared with placebo. The safety profile of QNASL was also similar to placebo. The most commonly reported adverse events for either treatment group were epistaxis and headache.
In August 2011, the US Food and Drug Administration (FDA) accepted for review Teva's New Drug Application (NDA) filing for QNASL.
Teva Global Respiratory Research and Development senior VP Dr. Tushar Shah said, “Based on the timing of the NDA acceptance and standard review timelines, we anticipate receiving FDA feedback on the approval status of QNASL in the near future.”
Published by Globes, Israel business news - www.globes-online.com - on March 5, 2012
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