COL-1077 is being developed as a sustained-release lidocaine gel for vaginal administration, intended as an acute-use anesthetic during minimally invasive gynecologic procedures. Approximately five million gynecological procedures are performed in the U.S. annually, representing a significant need for a safe and effective localized pain treatment for women undergoing these procedures.
The Company expects to commence a Phase II clinical trial in the second quarter of 2015. This trial will be a multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of a single dose of COL-1077 in women undergoing transvaginal pipelle-directed endometrial biopsy. Clinical trial supplies for the Phase II trial will be produced at the Company's Nottingham facility.
Columbia is focused on the development of specialty pharmaceuticals for women's health, building on the global CRINONE® franchise. The Company's product pipeline will leverage the 505(b)2 regulatory pathway, when possible, with new formulations of existing pharmaceuticals. With funding from operating cash flows, and internal expertise in formulation and pharmaceutical development, Columbia's strategy is to advance product candidates through Phase II proof-of-concept and selectively partner for later stage clinical trials and commercialization.
Columbia is actively evaluating new product opportunities for advancement into development. Additional programs will be announced as they clear internal development hurdles, including intellectual property filings, commercial assessments, and clinical development plans.
About Columbia Laboratories
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