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ASTEPRO Antihistamine Spray Tolerability

In a two-week clinical trial, 835 patients 12 years of age and older with seasonal allergic rhinitis were treated with one of six treatments: one spray per nostril of either ASTEPRO Nasal Spray, Astelin Nasal Spray or placebo twice daily; or 2 sprays per nostril of ASTEPRO Nasal Spray, Astelin Nasal Spray, or placebo twice daily.

Overall, adverse reactions were more common on the ASTEPRO Nasal Spray treatment group (21-28%) than in the placebo group (16-20%). Overall, fewer than 1% of patients discontinued due to adverse reactions and withdrawal due to adverse reactions was similar among the treatment groups.¹

In a 6-month, open-label, active-controlled, long-term safety trial, 555 patients 12 years of age and older with perennial allergic and/or nonallergic rhinitis were treated with ASTEPRO Nasal Spray two sprays per nostril twice daily or Astelin Nasal Spray two sprays per nostril twice daily.

The most frequently reported adverse reactions were headache, bitter taste, epistaxis, and nasopharyngitis and were generally similar between treatment groups. Focused nasal examinations were performed and showed that the incidence of nasal mucosal ulceration in each treatment group was approximately 1.5% at baseline and approximately 4% throughout the 6-month treatment period. In each treatment group, 3% - 5% of patients had mild epistaxis. No patients had reports of nasal septal perforation or severe epistaxis.

¹ASTEPRO package insert. Somerset, NJ: Meda Pharmaceuticals Inc; 2008.