Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration (FDA) has accepted for filing Teva's New Drug Application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA), a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). Teva's NDA was submitted to the FDA on May 24, 2011.
The submission is based on a comprehensive clinical development programme including results from two phase III clinical trials assessing the safety and efficacy of BDP Nasal HFA in the treatment of SAR and PAR. In both trials, BDP Nasal HFA demonstrated significant improvement in nasal symptom scores of sneezing, runny nose, nasal itching and nasal congestion versus placebo. BDP Nasal HFA was generally well tolerated and the safety profile was similar to that of placebo.
"BDP Nasal HFA has demonstrated promising results in the treatment of both SAR and PAR, and we remain committed to addressing unmet needs and dissatisfaction with currently available treatments among the 60 million patients in the US who suffer from allergic rhinitis," said Professor Yitzhak Peterburg, Teva's Group vice president, global branded products.
Currently, the only intranasal corticosteroids available for the treatment of SAR and PAR are products with an aqueous or "wet" spray. In contrast, BDP Nasal HFA is delivered as a pressurized, non-aqueous aerosol solution, or "dry" spray, propelled by HFA, which is environmentally friendly. Recent survey results have found that some nasal allergy patients who used an intranasal corticosteroid spray in the last year reported dripping in the throat as a moderately or extremely bothersome side effect. Patients reported being less satisfied with current nasal sprays when they experienced discomfort from the spray or when they felt the medication drip down the back of their throats. Healthcare providers and specialists also reported patient dissatisfaction with current nasal sprays due to the bothersome side effects associated with these treatments.
"We are encouraged by the positive safety and efficacy results from both the phase III trials evaluating BDP Nasal HFA in seasonal and perennial allergic rhinitis," said Eli O. Meltzer, M.D., Allergy & Asthma Medical Group & Research Center, San Diego, CA. "The new nasal aerosol delivery system which propels an odorless, non-aqueous spray also offers a built-in dose counter."
The phase III, randomized, double-blind, placebo-controlled, parallel-group study assessed the efficacy and safety of BDP Nasal HFA in the treatment of SAR in subjects 12 years of age and older. At four U.S. investigational sites, 340 SAR patients were randomized to receive 320 mcg once-daily of BDP Nasal HFA or placebo as a nasal aerosol over a two-week period during the Mountain Cedar pollen season.
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. The symptom improvements were evident by day two and were maintained throughout the treatment period. 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 sneezing, runny nose, nasal itching and nasal congestion demonstrated significant improvement with BDP Nasal HFA versus placebo.
BDP Nasal HFA was also generally well tolerated and the safety profile was similar to that of placebo. The most common treatment-emergent adverse event was nasal discomfort that was similarly reported for both BDP Nasal HFA (6.6%) and placebo (5.8%).
The phase III, randomized, double-blind, placebo-controlled, parallel-group clinical study assessed the efficacy and safety of BDP Nasal HFA 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 BDP Nasal HFA (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). 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.
BDP Nasal HFA was also generally well tolerated and the safety profile was similar to that of placebo. The most common treatment-emergent adverse events were nasal discomfort (5.5% for BDP Nasal HFA vs. 4.2% for placebo) and nosebleed (3.8% for BDP Nasal HFA vs. 6.7% for placebo) that were similar with both treatments.
BDP Nasal HFA is an investigational intranasal corticosteroid in development for the treatment of allergic rhinitis. The product utilizes the same chemical formulation as QVAR (beclomethasone dipropionate HFA) Inhalation Aerosol, an inhaled corticosteroid (ICS) approved by the US Food and Drug Administration (FDA) for the maintenance treatment of asthma. BDP Nasal HFA is administered as a non-aqueous solution or "dry spray" delivered by hydrofluoroalkane (HFA), an environmentally friendly propellant.
QVAR is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age or older. QVAR is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR may reduce or eliminate the need for systemic corticosteroids.
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.