PHILADELPHIA, March 17 -- Olopatadine in nasal spray form may provide an option to azelastine (Astelin) for seasonal allergic rhinitis, a researcher said here.
An investigational nasal-spray version of olopatadine (Patanase) was significantly more effective than placebo and non-inferior to azelastine in a randomized, double-blind phase III trial, said Dale Mohar, M.D., of Kerrville Allergy & Asthma Associates in Kerrville, Texas.
Moreover, olopatadine seems to taste better than azelastine, the chief drawback of which is a pronounced bitter taste, Dr. Mohar said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
"The incidence of bad taste was much lower," Dr. Mohar said.
Action Points
- Explain to interested patients that olopatadine nasal spray seems to be as effective as azelastine with less bitter taste.
- Point out that olopatadine as a nasal spray is investigational and is not FDA-approved.
- Point out that the results were presented orally at a conference and should be considered preliminary until they are published in a peer-reviewed journal.
In this 544-patient trial, 12.2% of patients taking olopatadine reported some degree of bitter taste, compared with 19.7% of those taking azelastine (P=0.05).
No patients reported severe bitter taste with olopatadine and about 75% of those reporting a bitter taste with the drug said it was mild.
Among patients reporting bitter taste with azelastine, more than 5% rated it as severe and about 55% said it was moderate.
The difference in intensity was statistically significant (P=0.0052).
Dr. Mohar said the bitter taste can have an effect on compliance, particularly in younger patients. "If it tastes real bad, you can't get the kids to take it," he said.
About 180 patients per group were assigned to receive olopatadine (0.6% concentration), azelastine (0.1%), or vehicle, two sprays twice daily for two weeks. The study began with a vehicle-only washout period.
Patients recorded symptoms twice a day in an electronic diary.
Efficacy was measured by reduction in Total Nasal Symptom Scores from baseline. The results were as follows:
- Vehicle: -18.4%
- Azelastine: -29.9%
- Olopatadine: -26.8%
The difference between active drugs was not significant. Both drugs were significantly more effective than vehicle (P<0.003).
Dr. Mohar said the two-week study period was appropriate for a seasonal allergy product intended for quick symptom relief.
Olopatadine is currently approved as an eye drop (Patanol) for allergic conjunctivitis, as is azelastine (Optivar).
Currently, azelastine is the only prescription antihistamine approved as a nasal spray.
Dr. Mohar said both azelastine and olopatadine are extremely fast-acting relative to over-the-counter antihistamines, with symptom relief in five minutes.
The company manufacturing olopatadine, Alcon, has filed for marketing approval for the nasal spray version but has not yet received it.
| The study was supported by Alcon, manufacturer of olopatadine. Dr. Mohar did not report other potential conflicts of interest. |
Primary Source
AAAAI Meeting
Source Reference: Mohar D, et al "Olopatadine nasal spray 0.6% is superior to vehicle and non-inferior to azelastine nasal spray 0.1% when dosed twice-daily for the treatment of seasonal allergic rhinitis" AAAAI Meeting 2008; Abstract 192.