RxTrials Institute Drug Pipeline Alert

The FDA has approved Alcon’s Patanase, an antihistamine nasal spray, to treat seasonal allergic rhinitis in patients older than 12.

The approval of Patanase (olopatadine hydrochloride) was based on data from multiple two-week, randomized, double-blind clinical trials in seasonal allergic rhinitis patients. The studies were conducted to determine the drug’s ability to relieve allergy symptoms based on total nasal symptom scores, Alcon said.

Additionally, onset of action was evaluated in three environmental exposure unit studies. In these studies, patients were exposed to high levels of pollen and treated with either Patanase or placebo nasal spray.

The steroid-free nasal spray Patanase will be available in May. Other brand nasal sprays in the U.S. are corticosteroid allergy treatments that do not cause drowsiness. They include Schering-Plough’s Nasonex (mometasone furoate monohydrate) and sanofi-aventis’ Nasacort AQ (triamcinolone acetonide).