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news.Collegium Pharmaceutical has announced that the FDA has approved AllerNaze nasal spray, 50mcg, an aqueous based intranasal steroid indicated for the once daily treatment of nasal symptoms associated with both seasonal allergic rhinitis and perennial allergic rhinitis in adults and children 12 years of age and older.
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The safety and efficacy of AllerNaze nasal spray in both seasonal allergic rhinitis and perennial allergic rhinitis 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 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 US and international markets.
Michael Heffernan, president of Collegium, said: We are very pleased to have received FDA approval for AllerNaze nasal spray. 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.