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 linical studies."
Dysmenorrhea is characterized by recurrent uterine cramping and pain before and during menses. 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 is a specialty pharmaceutical company focused on developing and marketing products for the women's healthcare and endocrinology markets using its novel bioadhesive drug delivery technology. Columbia markets CRINONE(R) 8% (progesterone gel) and PROCHIEVE(R) 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency and PROCHIEVE 4% (progesterone gel) for the treatment of secondary amenorrhea. The Company also markets STRIANT(R) (testosterone buccal system) for the treatment of hypogonadism in men. For more information, please visit 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" and similar expressions. Such forward-looking statements are subject to certain risks and uncertainties; actual results may differ materially fr om 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 following: the successful marketing of CRINONE(R) 8% (progesterone gel), PROCHIEVE(R) 8% (progesterone gel), PROCHIEVE 4% (progesterone gel), and STRIANT(R) (testosterone buccal system) in the U.S.; the timely and successful development of new products, including determining the clinical and regulatory path for possible development of PROCHIEVE 8% for the prevention of preterm birth; the timely and successful completion of clinical studies, including the clinical studies for our vaginally-administered lidocaine product candidate; 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(R), PROCHIEVE(R) and STRIANT(R) are registered trademarks of Columbia Laboratories, Inc.
Columbia Laboratories, Inc.
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