FDA Approved Drugs » 2012
Medical Areas: Immunology | Otolaryngology (Ear, Nose, Throat) | Pediatrics/Neonatology | Pulmonary/Respiratory Diseases | Family Medicine | Infections and Infectious Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Teva Pharmaceutical
Approval Status: Approved March 2012
Treatment Area: seasonal and perennial allergic rhinitis
Qnasl nasal aerosol contains the active ingredient beclomethasone dipropionate, an anti-inflammatory steroid.
Qnasl is specifically indicated for the treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.
Qnasl is supplied as a non-aqueous nasal spray solution designed for intranasal inhalation. The recommended dose of Qnasl is 320 mcg per day administered as two nasal aerosol sprays in each nostril (80 mcg/aerosol spray) once daily (maximum total daily dose of four nasal aerosol sprays per day).
FDA ApprovalThe FDA approval of Qnasl was based on three randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials in a total of 1,049 subjects. The three clinical trials included one two-week dose-ranging trial in subjects with seasonal allergic rhinitis, one two-week efficacy trial in subjects with seasonal allergic rhinitis, and one six-week efficacy trial in subjects with perennial allergic rhinitis. The subjects received Qnasl 320 mcg once daily administered as two sprays in each nostril or placebo. Assessment of efficacy was based on the total nasal symptom score (TNSS), with the primary endpoint of improvement on TNSS versus placebo when measured from baseline to the end of treatment. TNSS was measured as reflective (rTNSS) or instantaneous (iTNSS). rTNSS required the subjects to record symptom severity over the previous 12 hours; iTNSS required the subjects to record symptom severity over the previous 10 minutes.Dose-Ranging Trial:This two-week trial evaluated the efficacy of three doses of beclomethasone dipropionate nasal aerosol (80, 160, and 320 mcg, once daily) in
subjects with seasonal allergic rhinitis. The 320 mcg/day dose resulted in statistically significant improvements compared with placebo in the primary efficacy endpoint, rTNSS, as well as a statistically significant decrease in morning iTNSS versus placebo, indicating that the effect was maintained over the 24-hour dosing interval.Seasonal and Perennial Allergic Rhinitis Trials:In both trials once daily treatment with Qnasl nasal aerosol for two weeks in subjects with seasonal allergic rhinitis and for six weeks in subjects with perennial allergic rhinitis resulted in statistically significant greater decreases from baseline in the rTNSS and morning iTNSS than placebo.
Adverse events associated with the use of Qnasl may include, but are not limited to, the following:
Qnasl contains the active ingredient beclomethasone dipropionate, an antiinflammatory steroid. Beclomethasone dipropionate is a prodrug that is extensively converted to the active metabolite, beclomethasone-17-monopropionate. The precise mechanism through which beclomethasone dipropionate affects rhinitis symptoms is unknown. Corticosteroids have been shown to have multiple anti-inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and the release of inflammatory mediators.
For additional information regarding Qnasl or seasonal and perennial allergic rhinitis, please visit the Qnasl web page.