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Columbia to begin Phase II trial of lidocaine bioadhesive 10% gel

US-based Columbia Laboratories (CBRX) is planning to start a Phase II clinical trial for COL-1077, a lidocaine bioadhesive 10% gel, in women undergoing transvaginal pipelle-directed endometrial biopsy.

The proposed plan follows a pre-investigational new drug (IND) submission feedback from the US Food and Drug Administration (FDA), which provided guidance on the clinical plan, manufacturing approach, and clinical study design.

The company intends to begin the multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial in the second quarter of 2015.

Designed as a sustained-release lidocaine gel for vaginal administration, COL-1077 is intended as an acute-use anesthetic during minimally invasive gynecologic procedures.

The trial will evaluate the efficacy and safety of a single dose of COL-1077 in these patients and the clinical trial supplies will be produced at the company’s Nottingham facility.

In the US, around five million gynecological procedures are performed every year, representing a significant need for a safe and effective localized pain treatment for women undergoing these procedures.

Columbia Laboratories president and chief executive officer Frank Condella said: "The FDA’s feedback on COL-1077 is a critical next step in the advancement of this program to address an unmet medical need in women’s health.

"Based on data from previous clinical studies, along with this FDA guidance, we believe that COL-1077 is well-positioned to immediately and successfully transition into the clinic."

The company is scheduled to submit its IND application in March 2015.