Columbia Laboratories Reports Results From Phase II Clinical Trial Of Vaginally-administered Lidocaine For Dysmenorrhea

Main Category: Women's Health / Gynecology
Also Included In: Pain / Anesthetics;  Clinical Trials / Drug Trials
Article Date: 01 Oct 2008 - 8:00 PDT

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Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced results from its Phase II study of vaginally-administered lidocaine, which the Company is investigating for the prevention and treatment of dysmenorrhea. No treatment currently exists to prevent dysmenorrhea.

Seventy women with a history of moderate-to-severe dysmenorrhea participated in this first documented attempt to show prevention of uterine cramping and pain. This double-blind, placebo-controlled clinical trial used a cross-over design in which each subject received either the lidocaine product candidate or placebo in consecutive menstrual cycles and thus acted as her own control. The primary endpoint of the study was to show a difference between lidocaine and placebo in terms of the time-weighted average patient-assessed pain intensity over four treatment days. Data from the clinical trial did not show a significant difference between the pain scores for the lidocaine and placebo treatment cycles. Patients in the clinical trial were also asked to make a subjective assessment of the treatment at the end of each cycle, and to compare the first and second cycles to one another. While complete analysis of these secondary data is ongoing, top line data suggest a trend for patients to favor their lidocaine treatment cycle. The clinical trial did not reveal any significant adverse events and those adverse events that occurred were similar in both kind and frequency for lidocaine and placebo.

"Data from our initial dysmenorrhea clinical study suggest a trend for a positive lidocaine effect among secondary data endpoints for the patients' overall assessments of each menstrual cycle, although the clinical trial did not show a difference between lidocaine and placebo in patient-assessed pain scores, our primary endpoint," stated Robert S. Mills, president and chief executive officer of Columbia Laboratories. "We are evaluating if it is feasible to enhance this lidocaine effect through modifications to the dosing regimen and treatment protocol. We are encouraged that the study showed no difference in safety for our lidocaine product candidate compared to placebo. Our next steps will be to conduct a full analysis of these study results and determine the best way to build on these findings. I look forward to reporting more about our ongoing analysis of the study results on our conference call to report the Company's third quarter results."

About Dysmenorrhea

Dysmenorrhea is characterized by recurrent uterine cramping and pain before and during menses (menstruation). This common, painful women's health condition seriously affects 12% of all menstruating women in the U.S. between the ages of 20 and 45, or about 5.6 million women. It is estimated to account for 600 million lost work hours and approximately $2 billion in lost productivity annually. Current treatments address the pain but not the underlying problem. Columbia's hypothesis is that administering lidocaine vaginally, using its proprietary bioadhesive delivery system (BDS) technology, can minimize or prevent the severe cramping that results in the debilitating pain of dysmenorrhea.

About Columbia Laboratories

Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and marketing products for the women's healthcare and endocrinology markets that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE® 8% (progesterone gel) and PROCHIEVE® 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency. The Company also markets STRIANT® (testosterone buccal system) for the treatment of hypogonadism in men. The Company's partners market CRINONE® 8%, STRIANT®, and three other products to additional U.S. and foreign markets. The Company's research and development programs include the PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study of PROCHIEVE® 8% to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy. For more information, please visit http://www.columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, and clinical research programs, which statements are indicated by the words "will," "plan," "expect," "suggest," "trend," and similar expressions. Such forward-looking statements are subject to certain risks and uncertainties; actual results may differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to: the successful marketing of CRINONE® 8% (progesterone gel), PROCHIEVE® 8% (progesterone gel) and STRIANT® (testosterone buccal system) in the U.S.; the timely and successful development of new products, including vaginal lidocaine to prevent and treat dysmenorrhea, and new indications for current products, including PROCHIEVE® 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy; the timely and successful completion of clinical studies, including the ongoing Phase III PREGNANT (PROCHIEVE® Extending GestatioN A New Therapy) Study of PROCHIEVE® 8% in short cervix patients; success in obtaining acceptance and approval of new products and new indications for current products by the FDA and international regulatory agencies, the impact of competitive products and pricing; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to publicly update any forward-looking statements.

CRINONE®, PROCHIEVE® and STRIANT® are registered trademarks of Columbia Laboratories, Inc.

Columbia Laboratories

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