The US FDA has accepted the new drug application (NDA) filed by Teva on May 24, 2011 for its beclomethasone dipropionate (BDP) hydrofluoroalkane nasal spray for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). The BDP Nasal HFA spray uses the same formulation as Teva’s Qvar inhalation aerosol, an inhaled corticosteroid (ICS) already on the market, and would be the first “dry” or non-aqueous nasal spray on the market if approved.
Teva Group VP, Global Branded Products Yitzhak Peterburg said, “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.”
According to the company, two Phase 3 trials have demonstrated that the BDP Nasal HFA significantly reduces nasal symptoms in patients with SAR and PAR compared to placebo and is well tolerated. Teva expects that patients will prefer a dry nasal spray to an aqueous spray that may drip down the backs of their throats.
Read the Teva press release.
