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news.Collegium Pharmaceutical has reported that it plans to proceed with a Phase III clinical program to evaluate COL 118, its novel modified release combination antihistamine for the treatment of allergic rhinitis.
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Collegium submitted its proposed pivotal Phase III clinical protocol to the FDA for its review and comment. After receiving positive feedback and reconfirming the basis of approval requirements, Collegium will continue developing the product.
The goal of the Phase III clinical program is to demonstrate that the combination is more effective than the individual components in the treatment of allergic rhinitis as determined by the total nasal symptom score. Once approved, COL 118 will be available as an over the counter product.
The company is currently manufacturing clinical trial material for the upcoming Phase III program. The company expects that the Phase III clinical program will be ready to commence in early 2008.
Michael Heffernan, president of Collegium, said: “In addition to implementing our Phase III program we are currently evaluating our commercial options for the product.”