( LIVINGSTON N.J.--(BUSINESS WIRE)--Jun ...)Columbia Laboratories Reports Positive Results from Multi-dose,Pharmacokinetic Study of Vaginally-administered Lidocaine,Health

LIVINGSTON, N.J.--(BUSINESS WIRE)--Jun 27, 2007 - Columbia Laboratories, Inc. (NASDAQ: CBRX) today announced positive results from a recently-completed multi-dose pharmacokinetic study of vaginally-administered lidocaine, which the Company is developing to prevent and treat dysmenorrhea.

This 42-subject study was designed to provide data on blood levels associated with the Company's bioadhesive vaginal lidocaine formulation at three dose strengths over multiple doses. The cohort was randomly divided into three groups, which corresponded to the three different dose strengths of the lidocaine product candidate.

"For each of the dose levels studied, use of our bioadhesive vaginal lidocaine formulation over four consecutive days was associated with blood levels that are well within an accepted range," stated George Creasy, M.D., FACOG, Columbia's vice president of clinical research and development. "At the highest dose, those blood levels are what we anticipated based on extrapolation of data from the prior, single-administration pharmacokinetic study. This indicates a positive safety profile for our lidocaine product candidate relative to the known systemic effects of lidocaine."

"This positive data strengthens our resolve to speed the path to market for our lidocaine product. We received approval from the Institutional Review Board to conduct a Phase II cross-over study with this drug candidate and we will begin recruiting patients in this study very soon," stated Robert S. Mills, president and chief executive officer of Columbia Laboratories. "There are approximately 5.6 million women who suffer from the painful menstrual cramping that characterizes dysmenorrhea, which limits their normal activities and causes them to lose time from school or work. We believe our lidocaine product can fill a real unmet medical need and improve the lives of these women, assuming positive data in current and future c
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