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Collegium Pharmaceutical to Advance its Allergic Rhinitis Product into Phase III Trials
CUMBERLAND, RI-- (BUSINESS WIRE)—December 17, 2007—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).
Collegium had previously completed a “Proof of Concept” (POC) trial that was initiated to investigate the potential for COL 118 to meet its desired endpoints. The approved commercially available components of the product candidate were used for this trial. A total of 76 patients were enrolled in a three (3) arm, randomized, placebo controlled, multi-center trial during the fall allergy season in four (4) sites in the US. The trial was designed to test a combination product against one of its individual components and against placebo. The primary endpoint was reduction in Total Nasal Symptom Score (TNSS). The results of the trial provided sufficient indication that Collegium’s product candidate would be able to be differentiated from one of its individual active components and placebo in the reduction of the primary endpoint that was requested by the FDA. In addition, the combination product used in this trial exhibited an adverse event profile similar to that of the single active component alone and placebo. The trial provided the Company with information that will guide its Phase III protocol design including the estimated sample size required to achieve statistical significance.
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.
In the United States, allergic rhinitis affects approximately 40 million people, according to the American Academy of Allergy, Asthma, and Immunology. Annual sales of allergic rhinitis products are currently estimated at greater than $4 billion per year in the U.S. Antihistamine products comprise a significant sector of this market. Antihistamines that are currently available for the treatment of allergic rhinitis include both first generation antihistamines which tend to have a sedating effect, such as diphenhydramine (e.g. Benadryl®), and the newer antihistamines which are considered less sedating, such as loratadine (e.g. Claritin®) and cetirizine (Zyrtec®). The antihistamine market growth is anticipated to be primarily in OTC products in the future.
"We believe that this product has the potential to address a large unmet patient need in the treatment of allergic rhinitis. A ‘once a day’ combination product such as COL 118 allows patients to take full advantage of the beneficial effects of a short acting sedating antihistamine at bedtime in addition to the benefits of a longer acting non-sedating antihistamine during the course of the day” said Michael Heffernan, R.Ph., President, Collegium Pharmaceutical. “In addition to implementing our Phase III program we are currently evaluating our commercial options for the product.”
About Collegium Pharmaceutical
Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through formulation based product improvements protected by intellectual property (IP). Collegium focuses on product development in respiratory diseases, CNS disorders, and skin and skin related disorders through its subsidiary, Onset Therapeutics (www.onsettx.com). For more information, visit the Company’s website at www.collegiumpharma.com.
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