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DGDispatch
New Antihistamine Nasal Spray Safe, with Less Incidence of Bad/Bitter Taste Versus Azelastine: Presented at ACAAI
By Corinna S. Bowser, MD
PHILADELPHIA, PA -- November 13, 2006 -- Olopatadine, an antihistamine nasal spray under development for allergic rhinitis, appears to be safe and may have a lower incidence of bad or bitter taste complaints compared with another antihistamine nasal spray, according to data presented here at the 2006 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI).
Olopatadine HCl 0.6% nasal spray, which contains an antihistamine and has mast cell stabilizing activity in vitro, was well tolerated, with a safety profile that was similar to that of azelastine HCl 0.1% nasal spray (Astelin), according to investigator Paul Ratner, MD, allergist in private practice and medical director, Sylvana Research Associates, San Antonio, Texas.
Taste perversion was significantly less common with the olopatadine spray, at 12.2% of patients compared with 19.7% for azelastine and 1.7% for placebo (P = .05). Mean intensity of taste perversion was lower for olopatadine vs azelastine (P < .0001); about 70% of the reports of taste perversion for olopatadine were classified as "mild" and almost 30% were "moderate". For azelastine, taste perversion was most commonly classified as moderate (approaching 60%) and some cases were classified as severe.
"There was significantly less taste perversion, which is something that patients on azelastine complain about," Dr. Ratner said in a presentation on November 11th. "I think there are enough complaints about it, clinically, that it is an issue."
In this randomized, placebo-controlled, multicenter parallel group study, patients received olopatadine, placebo, or azelastine twice daily for 2 weeks.
For 544 patients who completed treatment, olopatadine-related adverse events reported at a greater incidence versus placebo included taste perversion (12.2%), epistaxis (2.2%), nasal discomfort (1.7%), rhinitis (1.7%), and throat irritation (1.1%). Systemic effects included headache (1.7%), fatigue (1.7%), and dry mouth (1.1%). There were similar incidences of these adverse events for azelastine, with the exception of taste perversion.
One mild nasal ulcer, which resolved without treatment, was reported in the azelastine group. There were no clinically meaningful changes in blood pressure or pulse in any group, and there were no episodes of syncope, tachycardia/bradycardia, or rhythm abnormalities.
"Overall both drugs were safe, and both were well tolerated," Dr. Ratner said. "And of course, a lot of efficacy data is out there as well -- some of which has been published and some not-- that would imply that (olopatadine nasal spray) is an efficacious medication."
Olopatadine nasal spray contains the same active ingredient found in the prescription eye drops Patanol (olopatadine HCl ophthalmic solution 0.1%) and Pataday (olopatadine 0.2%). The nasal spray formulation is up for regulatory review and may be available in the United States in 2008.
[Presentation title: Comparative Safety of Olopatadine, Azelastine and Placebo Nasal Sprays in Patients With Seasonal Allergic Rhinitis. Abstract P203]
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