NASACORT HFA™ (triamcinolone acetonide)
NASACORT HFA™ is an intranasal steroid formulated with a hydrofluoroalkane (HFA) propellant and delivered as a fine, dry mist in a small volume pressurized metered dose. Currently, only the water based liquid spray formulations of nasal steroids are available in the U.S. NASACORT HFA is being developed as a once-a-day treatment for nasal symptoms associated with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and children 6 years of age and older.
Acton plans to launch NASACORT HFA in the United States upon FDA approval including the resolution of certain technical issues related to manufacturing scale-up.
The clinical program of NASACORT HFA Nasal Aerosol included two Phase 3 studies conducted in the U.S. that involved 1,176 patients 12 to 83 years of age with allergic rhinitis, of which 729 patients were treated with NASACORT HFA Nasal Aerosol. One study was a two-week, double-blind, parallel-group, placebo-controlled trial comparing NASACORT HFA Nasal Aerosol to NASACORT Nasal Inhaler (triamcinolone acetonide CFC formulation) in 780 patients 18 years of age and older with seasonal allergic rhinitis.
In the two-week, double-blind study, NASACORT HFA Nasal Aerosol and NASACORT Nasal Inhaler (triamcinolone acetonide CFC formulation) were comparable, and both formulations showed a statistically significant reduction in symptoms of allergic rhinitis. There were no significant differences in the effectiveness of NASACORT HFA Nasal Aerosol across subgroups of patients defined by gender, age, or race.
The second study was a 12-month open-label safety in 396 patients with perenninal allergic rhinitis.
Adverse events occurring with an incidence of 3% or greater and more commonly with NASACORT HFA Nasal Aerosol arms compared to placebo irrespective of drug relationship include sneezing, headache, nasal irritation and rhinitis.Safety Warnings
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of withdrawal.
The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.About Allergic Rhinitis
Allergic rhinitis is a chronic inflammatory disease and includes a collection of symptoms predominantly in the nose and eyes, including sneezing, stuffy nose, and nasal itch. Seasonal allergic rhinitis (SAR) is sometimes referred to as hay fever, and is caused by an allergy to pollen.
Allergic rhinitis affects an estimated 50 million people in the U.S. and is the fifth leading chronic disease resulting in ~4 million missed or lost workdays each year and costing more than $700 million in lost productivity.
Each year, nearly 17 million physician office visits are attributed to allergic rhinitis, with seasonal allergic rhinitis accounting for more than half of all allergy visits.