CUMBERLAND, R.I.--(BUSINESS WIRE)--Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, announced today that it plans to proceed with its Phase III clinical program to evaluate COL 118, its novel modified release combination antihistamine for the treatment of allergic rhinitis. This is following a meeting with the U.S. Food and Drug Administration (FDA). 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. COL 118 is an orally administered, modified release formulation that combines a short acting sedating antihistamine with a longer acting non-sedating antihistamine and is intended to be taken at bedtime. 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 (TNSS). Once approved, COL 118 will be available as an over the counter product (OTC).
