Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, has announced that the FDA has approved AllerNaze™ (triamcinolone acetonide, USP) Nasal Spray, 50 mcg, an aqueous based intranasal steroid indicated for the once daily treatment of nasal symptoms associated with both seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and children twelve (12) years of age and older. AllerNaze™ will compete in the approximately $2.5 billion a year U.S. market for nasal inhaled steroids for the treatment of allergic rhinitis. Allergic rhinitis is the most common allergic condition and is increasing in prevalence. Allergic rhinitis is the medical term for the inflammation of the nasal membranes and is characterized primarily by a runny nose, which is the most common allergy symptom. Seasonal allergic rhinitis is the most common allergic disease. Approximately 35 million Americans suffer from this condition. The ailment’s classic symptoms are watery nasal discharge, fits of sneezing, and itching that can affect not just the nasal passage but also the roof of the mouth, throat and the Eustachian tubes which connect the middle ear to the back of the throat. The safety and efficacy of AllerNaze™ Nasal Spray in both SAR and PAR have been well established in 14 controlled clinical trials involving almost 1,200 subjects. The studies assessed the safety and effectiveness of AllerNaze™ in treating the symptoms (runny nose, nasal itching, sneezing, and nasal congestion) in patients with allergic rhinitis. The Company intends to launch the product with a marketing partner and is actively discussing the opportunity with potential partners for both the U.S. and international markets. “We are very pleased to have received FDA approval for AllerNaze™ Nasal Spray” said Michael Heffernan, President of Collegium. “We believe that the benefits of AllerNaze’s novel aqueous based solution formulation containing a proven safe and effective active ingredient (triamcinolone acetonide) will provide another alternative to the currently available options for the treatment of allergic rhinitis. We intend to direct our focus on identifying the best commercial marketing partner for the product in both the US and select international markets.”
