Once-Daily Azelastine Nasal Spray Approved for Seasonal Allergies

Yael Waknine

September 02, 2009

September 2, 2009 — The US Food and Drug Administration has approved azelastine HCl 0.15% nasal spray (Astepro Once-Daily; Meda AB) for the treatment of seasonal and perennial allergic rhinitis in patients 12 years and older.

The product is 50% more concentrated than the original Astepro formulation and represents the first nasal antihistamine to offer once-daily dosing for patients with seasonal allergies. A twice-daily dose of 2 sprays per nostril is recommended for those with year-round allergies.

According to a company news release, the formulation has demonstrated a rapid onset of action, relieving symptoms within 30 to 45 minutes of dosing.

Azelastine provides fast-acting relief and is applied right at the site — in the nasal passage — to treat a broad spectrum of nasal symptoms, including congestion caused by indoor and outdoor allergies," said William Berger, MD, clinical professor in the Division of Allergy and Immunology at the University of California, in Irvine. "Based on demonstrated improvement in nasal allergy symptoms, [azelastine] 0.15% is a good first-line therapy option for seasonal and perennial allergic rhinitis patients suffering with nasal symptoms."

The efficacy of azelastine 0.15% nasal spray was demonstrated in 7 double-blind placebo-controlled 2- and 4-week phase 3 trials, in which its use significantly improved total nasal symptom score, a composite of rhinorrhea, nasal congestion, sneezing, and nasal itching scores.

Once- and twice-daily treatment with azelastine 0.15% nasal spray was generally well tolerated in these short-term studies; adverse events most commonly reported included bitter taste (4% and 6%, respectively), nasal discomfort (4% and 3%, respectively), epistaxis (2% and 1%, respectively), and sneezing (1% and 2%, respectively). Somnolence occurred in less than 1% of patients receiving active treatment.

In a 1-year long-term safety study of patients with perennial allergic rhinitis, adverse events associated with twice-daily use of azelastine 0.15% nasal spray included bitter taste, headache, sinusitis, and epistaxis. No severe epistaxis, nasal ulcerations, or septal perforations were observed.

Azelastine 0.1% nasal spray was previously approved for the twice-daily treatment of seasonal allergic rhinitis in patients 12 years and older.